Is this your brand? Sign in to claim ownership.
Sign in to claim this brandMaquet Cardiovascular LLC
United States·US-MF-000011693
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 45, Barbour Pond Drive, Wayne, United States
- Website
- www.getinge.com
- —
- —
- [email protected]
- Phone
- +1 201-675-2846
- PRRC Contact
- Francisco Vicenty
- EUDAMED SRN
- US-MF-000011693
- FDA FEI Number
- 2242352
- DUNS Number
- —
Catalogue (231)
Page 2 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Exxcel Soft ePTFE Vascular Graft | M002004947580 | FDA UDI | Class II | Active |
| Exxcel Soft ePTFE Vascular Graft | M002004810880 | FDA UDI | Class II | Active |
| Exxcel Soft ePTFE Vascular Graft | M002004910580 | FDA UDI | Class II | Active |
| Exxcel Soft ePTFE Vascular Graft | M002004930460 | FDA UDI | Class II | Active |
| Vasoview Hemopro 3 Power Adapter | VH-6020 | FDA UDI | Class II | Unknown |
| Acrobat-i Positioner | XP-5000Z | FDA UDI | Class I | Active |
| Vasoview Hemopro 2 | VH-4000 | FDA UDI | Class II | Active |
| Fusion Supported Vascular Grafts | M002015030410 | FDA UDI | Class II | Active |
| Axius Coronary Shunt | OF-2000L | FDA UDI | Class II | Active |
| Fusion Supported Vascular Grafts | M002015030680 | FDA UDI | Class II | Active |
| Fusion Supported Vascular Grafts | M002015030470 | FDA UDI | Class II | Active |
| Fusion Bioline Vascular Grafts | M00201501088B0 | FDA UDI | Class II | Active |
| Exxcel Soft ePTFE Vascular Graft | M002004930860 | FDA UDI | Class II | Active |
| HeartString III Proximal Seal | HS-3045 | FDA UDI | Class II | Active |
| Fusion Supported Vascular Grafts | M002015030860 | FDA UDI | Class II | Active |
| Exxcel Soft ePTFE Vascular Graft | M002004830560 | FDA UDI | Class II | Active |
| Hemopro, power cord, Switzerland | C-VH-3015 | EUDAMEDFDA UDI | Class II | Active |
| Exxcel Soft ePTFE Vascular Graft | M002004910750 | FDA UDI | Class II | Active |
| Fusion Supported Vascular Grafts | M002015030810 | FDA UDI | Class II | Active |
| Exxcel Soft ePTFE Vascular Graft | M002004895470 | FDA UDI | Class II | Active |
| Fusion Bioline Vascular Grafts | M00201501047B0 | FDA UDI | Class II | Active |
| Axius Coronary Shunt | OF-1000 | FDA UDI | Class II | Active |
| Exxcel Soft ePTFE Vascular Graft | M002004944280 | FDA UDI | Class II | Active |
| Fusion Bioline Supported Vascular Grafts | M00201503087B0 | FDA UDI | Class II | Active |
| Axius Coronary Shunt | OF-1750 | FDA UDI | Class II | Active |
| Exxcel Soft ePTFE Vascular Graft | M002004910560 | FDA UDI | Class II | Active |
| Exxcel Soft ePTFE Vascular Graft | M002004948780 | FDA UDI | Class II | Active |
| Exxcel Soft ePTFE Vascular Graft | M002004830860 | FDA UDI | Class II | Active |
| BiPolar Cable | C-2838 | FDA UDI | Class II | Active |
| Vasoview Hemopro, OUS | VH-3000-W | FDA UDI | Class II | Unknown |
| Ultima Stabilizer | OM-2001S | FDA UDI | Class I | Active |
| Fusion Bioline Supported Vascular Grafts | M00201503081B0 | FDA UDI | Class II | Active |
| Exxcel Soft ePTFE Vascular Graft | M002004943180 | FDA UDI | Class II | Active |
| Fusion Vascular Grafts | M002015010860 | FDA UDI | Class II | Active |
| ACCESSRAIL Platform (Standard Blade) | SB-1000 | EUDAMEDFDA UDI | Class I | Active |
| Fusion Supported Vascular Grafts | M002015030660 | FDA UDI | Class II | Active |
| Fusion Vascular Grafts | M002015010870 | FDA UDI | Class II | Active |
| Fusion Bioline Vascular Grafts | M00201501066B0 | FDA UDI | Class II | Active |
| Fusion Bioline Supported Vascular Grafts | M00201503041B0 | FDA UDI | Class II | Active |
| Exxcel Soft ePTFE Vascular Graft | M002004848560 | FDA UDI | Class II | Active |
| Exxcel Soft ePTFE Vascular Graft | M002004830880 | FDA UDI | Class II | Active |
| Axius Coronary Shunt | OF-3500 | FDA UDI | Class II | Active |
| Exxcel Soft ePTFE Vascular Graft | M002004947560 | FDA UDI | Class II | Active |
| Fusion Bioline Vascular Grafts | M00201501087B0 | FDA UDI | Class II | Active |
| Vasoview Hemopro | VH-3000 | FDA UDI | Class II | Unknown |
| Exxcel Soft ePTFE Vascular Graft | M002004910410 | FDA UDI | Class II | Active |
| Fusion Bioline Vascular Grafts | M00201501048B0 | FDA UDI | Class II | Active |
| Axius Coronary Shunt | OF-2750 | FDA UDI | Class II | Active |
| Exxcel Soft ePTFE Vascular Graft | M002004845060 | FDA UDI | Class II | Active |
| Exxcel Soft ePTFE Vascular Graft | M002004910260 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (100)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 15, 2025 | Z-2588-2025 | — | open, classified | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis. |
| Aug 15, 2025 | Z-2586-2025 | — | open, classified | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis. |
| Aug 15, 2025 | Z-2587-2025 | — | open, classified | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis. |
| Aug 6, 2025 | Z-2636-2025 | — | open, classified | Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws. |
| Mar 20, 2025 | Z-1622-2025 | — | open, classified | There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while in use. Maquet/Getinge determined that the issue was limited to the units of VH-4000 and VH-4001 manufactured with ceramic C-Ring, and the ceramic C-Ring was implemented in the Hemopro 2 devices from November 5, 2024, through February 14, 2025. |
| Mar 10, 2025 | Z-1577-2025 | — | open, classified | Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up. |
| Dec 9, 2024 | Z-0711-2025 | — | open, classified | Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool |
| Dec 9, 2024 | Z-0712-2025 | — | open, classified | Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool |
| Oct 16, 2024 | Z-0485-2025 | — | open, classified | Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life. |
| Oct 16, 2024 | Z-0486-2025 | — | open, classified | Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life. |
| Oct 16, 2024 | Z-0484-2025 | — | open, classified | Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life. |
| Sep 20, 2024 | Z-0092-2025 | — | open, classified | There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use. |
| May 31, 2024 | Z-2337-2024 | — | open, classified | There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue. |
| May 31, 2024 | Z-2338-2024 | — | open, classified | There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue. |
| May 17, 2024 | Z-2176-2024 | — | open, classified | Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended. |
| May 17, 2024 | Z-2175-2024 | — | open, classified | Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended. |
| Dec 13, 2023 | Z-0709-2024 | — | open, classified | Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death. |
| Dec 13, 2023 | Z-0710-2024 | — | open, classified | Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death. |
| Dec 1, 2023 | Z-0723-2024 | — | open, classified | Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or peripheral bypass graft surgery. |
| Dec 1, 2023 | Z-0724-2024 | — | open, classified | Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or peripheral bypass graft surgery. |
| Oct 31, 2023 | Z-0589-2024 | — | open, classified | The Positioner Arm may not tighten or lock during normal use. |
| Sep 19, 2023 | Z-0210-2024 | — | open, classified | Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device. |
| Sep 13, 2023 | Z-0137-2024 | — | open, classified | Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previously placed bypass graft, or could result in procedural delay and/or conversion. |
| Jun 28, 2023 | Z-2272-2023 | — | open, classified | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion. |
| Jun 28, 2023 | Z-2274-2023 | — | open, classified | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion. |
| Jun 28, 2023 | Z-2273-2023 | — | open, classified | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion. |
| Jun 28, 2023 | Z-2271-2023 | — | open, classified | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion. |
| Mar 6, 2023 | Z-1336-2023 | — | open, classified | Some batches of product were not sterilized to their minimum sterilization specification. |
| Mar 6, 2023 | Z-1337-2023 | — | open, classified | Some batches of product were not sterilized to their minimum sterilization specification. |
| Mar 6, 2023 | Z-1335-2023 | — | open, classified | Some batches of product were not sterilized to their minimum sterilization specification. |
| Jan 30, 2023 | Z-1245-2023 | — | open, classified | One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to customers. Use of the affected graft may result in reduction of blood flow or unwanted tension causing bleeding and the formation of a pseudo-aneurysm. |
| Dec 22, 2022 | Z-0996-2023 | — | open, classified | Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event. |
| Dec 22, 2022 | Z-0995-2023 | — | open, classified | Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event. |
| Apr 29, 2022 | Z-1282-2022 | — | terminated | Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an Intergard Woven Straight graft of D: 32 mm and L: 30 cm |
| Feb 9, 2022 | Z-0887-2022 | — | open, classified | Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses. |
| Jan 14, 2022 | Z-0729-2022 | — | terminated | Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Straight Vascular Graft, D: 7 mm L: 60 cm). Mislabeled product could cause a disruption of the vascular anastomosis in the long term, creating a pseudo-aneurysm |
| Dec 1, 2021 | Z-0403-2022 | — | terminated | There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead of a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1260004700; 18 mm x 9 mm; REF Number M002020851890 or a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1259882880; 18 mm x 9 mm; Ref Number M002020851890. |
| Apr 7, 2020 | Z-1859-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1881-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1862-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1866-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1875-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1871-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1870-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1874-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1873-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1878-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1860-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1872-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1865-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1869-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1880-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1861-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1864-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1877-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1867-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1863-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1882-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1876-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1879-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 7, 2020 | Z-1868-2020 | — | terminated | Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| Apr 18, 2019 | Z-1607-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1633-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1585-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1591-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1511-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1613-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1545-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1564-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1621-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1514-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1622-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1575-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1625-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1589-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1510-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1517-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1543-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1568-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1638-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1612-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1529-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1508-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1537-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1604-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1614-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1657-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1556-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1673-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1596-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1601-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1656-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1648-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1624-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1554-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1598-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1677-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1523-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1639-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |
| Apr 18, 2019 | Z-1649-2019 | — | terminated | Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured |