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Sign in to claim this brandBard Access Systems, Inc.
United States·US-MF-000017720
Last updated September 17, 2026
What Bard Access Systems, Inc. makes
Bard Access Systems, Inc. manufactures peripherally-inserted central venous catheters, including midline and hemodialysis variants, as well as vascular port administration sets and catheters. Their portfolio also includes vascular intervention infusion catheters, wearable percutaneous catheter/tube holders, and electrocardiographic/magnetic navigation systems for central venous catheter placement. Additionally, they produce general-purpose ultrasound imaging systems and accessories for vascular port needle insertion.
The company’s devices are classified under FDA’s Class I, Class II, and Unclassified (U) categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Bard Access Systems, Inc. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 605 North, 5600 West, Salt Lake City, United States
- Website
- No website
- —
- —
- [email protected]
- Phone
- +1 801 230 5783
- PRRC Contact
- Nitin Patil
- EUDAMED SRN
- US-MF-000017720
- FDA FEI Number
- 3006260740
- DUNS Number
- —
Catalogue (4044)
Page 23 of 81| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Peripheral Catheter Insertion Kit | F120087T | FDA UDI | Class II | Active |
| PowerPICC Provena | S3173118P | FDA UDI | Class II | Active |
| Introducer Needle | 5584180 | FDA UDI | Class II | Unknown |
| Groshong | 7726950 | FDA UDI | Class II | Active |
| PowerPort, Groshong | 4708561 | FDA UDI | Class II | Active |
| BardPort | 0602180 | FDA UDI | Class II | Active |
| PowerGlide Pro | F122088PTX | FDA UDI | Class II | Active |
| PowerPICC Provena | CK000694 | FDA UDI | Class II | Active |
| Port Access Needle | 581114 | FDA UDI | Class II | Active |
| PowerPICC Catheter | 3275135 | FDA UDI | Class II | Active |
| PowerPICC Provena | CK001016 | FDA UDI | Class II | Active |
| Provena Midline | S4254108DCP | FDA UDI | Class II | Active |
| Brevia catheter | 5494150 | FDA UDI | Class II | Active |
| PowerPort ClearVUE, ChronoFlex Silk | 5608362 | FDA UDI | Class II | Active |
| PowerPICC SOLO | CK000976 | FDA UDI | Class II | Active |
| PowerPICC Provena | S1275108FD1 | FDA UDI | Class II | Active |
| PowerHickman | 0805815 | FDA UDI | Class II | Active |
| PowerPICC SOLO | CK000690 | FDA UDI | Class II | Active |
| Site~Rite 8 | SR8v2.0.2 | FDA UDI | Class II | Active |
| Port Access Needle | SHG622-100Y | FDA UDI | Class II | Active |
| Peripheral Catheter Insertion Kit | F118101 | FDA UDI | Class II | Active |
| DuoGlide catheter | 5624240 | FDA UDI | Class II | Active |
| SafeStep | CPA00042A | FDA UDI | Class II | Active |
| Midline Catheter Kit | PP4255108DGPX | FDA UDI | Class II | Active |
| AccuCath Ace | AC1181252 | FDA UDI | Class II | Active |
| PowerPICC | CK000514 | FDA UDI | Class II | Active |
| Zenysis Dual Lumen Acute Dialysis Catheter | A863200 | FDA UDI | Class II | Unknown |
| PowerPICC Provena | S1275108FD3 | FDA UDI | Class II | Active |
| PowerPICC Provena | CK001033 | FDA UDI | Class II | Active |
| PowerPICC SOLO | CK000544A | FDA UDI | Class II | Active |
| PowerPort M.R.I. | 1809601 | FDA UDI | Class II | Active |
| X-Port M.R.I., ChronoFlex | 0607760 | FDA UDI | Class II | Active |
| Provena Midline | CK001057 | FDA UDI | Class II | Active |
| Broviac | 0600540 | FDA UDI | Class II | Active |
| PowerPICC Provena | S9294118P | FDA UDI | Class II | Active |
| PowerPICC SOLO2 HF Catheter | 1395108QD | FDA UDI | Class II | Active |
| Port Access Needle | 573114 | FDA UDI | Class II | Unknown |
| PowerPICC Provena | S1173108D6 | FDA UDI | Class II | Active |
| Port Access Needle | SH22-100Y | FDA UDI | Class II | Active |
| Vaccess Lt Long-Term Hemodialysis Catheter | 5124310 | FDA UDI | Class II | Unknown |
| AllPoints Port Access System PowerLoc | AN672010B | FDA UDI | Class II | Active |
| PowerPICC SOLO | CK000576 | FDA UDI | Class II | Active |
| Niagara Slim-Cath catheter | 5436240 | FDA UDI | Class II | Active |
| PowerPICC Provena SOLO | CK000610A | FDA UDI | Class II | Active |
| Poly Per-Q-Cath Catheter | 3255105 | FDA UDI | Class II | Active |
| Peripheral Catheter Insertion Kit | F318087T | FDA UDI | Class II | Active |
| DuoGlide catheter | 5623240 | FDA UDI | Class II | Active |
| Vaccess Lt Long-Term Hemodialysis Catheter | 5124280 | FDA UDI | Class II | Unknown |
| PowerPICC | CK000096B | FDA UDI | Class II | Active |
| 044611812 | CK000895 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (76)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Bard Access Systems, Inc. has 76 recall records initiated between September 23, 2003, and March 11, 2025. The recalls include instances of compromised sterility due to open seals or improper packaging, incorrect sizing of components such as retainer clips or introducers, missing or misprinted pages in instruction booklets, and discrepancies in product labeling. Statuses recorded include open, classified, and terminated recalls, with reasons spanning packaging defects, labeling errors, and potential deviations in product specifications.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 11, 2025 | Z-1507-2025 | — | open, classified | Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy. |
| Jun 20, 2022 | Z-1397-2022 | — | open, classified | BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2) Stylet safety mechanism may not engage as the stylet is removed; 3) Metal discs in the powered driver may stick rendering the driver unusable. |
| May 19, 2021 | Z-1991-2021 | — | terminated | Catheter kits contained the incorrect micro-introducers. |
| May 19, 2021 | Z-1994-2021 | — | terminated | Catheter convenience kits contain the incorrect guidewire. Kits were labeled with 70cm guidewires, but contained a 50cm guidewire. |
| Apr 7, 2021 | Z-1661-2021 | — | terminated | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock |
| Apr 7, 2021 | Z-1667-2021 | — | terminated | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock |
| Apr 7, 2021 | Z-1653-2021 | — | terminated | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock |
| Apr 7, 2021 | Z-1668-2021 | — | terminated | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock |
| Apr 7, 2021 | Z-1655-2021 | — | terminated | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock |
| Apr 7, 2021 | Z-1659-2021 | — | terminated | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock |
| Apr 7, 2021 | Z-1652-2021 | — | terminated | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock |
| Apr 7, 2021 | Z-1662-2021 | — | terminated | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock |
| Apr 7, 2021 | Z-1658-2021 | — | terminated | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock |
| Apr 7, 2021 | Z-1656-2021 | — | terminated | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock |
| Apr 7, 2021 | Z-1657-2021 | — | terminated | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock |
| Apr 7, 2021 | Z-1664-2021 | — | terminated | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock |
| Apr 7, 2021 | Z-1666-2021 | — | terminated | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock |
| Apr 7, 2021 | Z-1654-2021 | — | terminated | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock |
| Apr 7, 2021 | Z-1660-2021 | — | terminated | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock |
| Apr 7, 2021 | Z-1669-2021 | — | terminated | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock |
| Apr 7, 2021 | Z-1665-2021 | — | terminated | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock |
| Apr 7, 2021 | Z-1663-2021 | — | terminated | Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock |
| Dec 28, 2017 | Z-0536-2018 | — | terminated | Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension leg junction. |
| Apr 25, 2017 | Z-2120-2017 | — | terminated | StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip. |
| Dec 19, 2016 | Z-0986-2017 | — | terminated | Bard Access Systems announces a voluntary field action for the SafeStep Huber Needle Set with Y-Injection Site and MiniLoc Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the needle length and gage differs from the length and gage described on the label. |
| Dec 19, 2016 | Z-0985-2017 | — | terminated | Bard Access Systems announces a voluntary field action for the SafeStep Huber Needle Set with Y-Injection Site and MiniLoc Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the needle length and gage differs from the length and gage described on the label. |
| Dec 9, 2016 | Z-0981-2017 | — | terminated | Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.). |
| Dec 9, 2016 | Z-0982-2017 | — | terminated | Bard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices because some single unit pouches have been released without unique product identifiers (product code, lot number, expiration date, etc.). |
| Jul 20, 2015 | Z-2808-2015 | — | terminated | Bard Access Systems is recalling marketing brochures for the PowerPICC and PowerPICC SOLO catheters due to incorrect indication for use contained in the brochure. |
| May 27, 2015 | Z-2048-2015 | — | terminated | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. |
| May 27, 2015 | Z-2050-2015 | — | terminated | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. |
| May 27, 2015 | Z-2047-2015 | — | terminated | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. |
| May 27, 2015 | Z-2049-2015 | — | terminated | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling. |
| Mar 13, 2015 | Z-1560-2015 | — | terminated | Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate label associated to the power injection IFU for the PowerLoc MAX Safety Infusion Set (SWIS) was attached to the outside of the unit pouch. |
| Nov 3, 2014 | Z-0493-2015 | — | terminated | Bard Access Systems is recalling GuardIVa (Ref. No. FP23AD006) from lot ASXHT003 because they were non-sterile unit samples which potentially could be used clinically. |
| Aug 8, 2014 | Z-1273-2015 | — | terminated | Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits. |
| Aug 8, 2014 | Z-1272-2015 | — | terminated | Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits. |
| Aug 8, 2014 | Z-1275-2015 | — | terminated | Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits. |
| Aug 8, 2014 | Z-1274-2015 | — | terminated | Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits. |
| Aug 8, 2014 | Z-1271-2015 | — | terminated | Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits. |
| Jun 24, 2014 | Z-1443-2015 | — | terminated | Potential for inadvertent scalpel stick injury involving the safety scalpel. |
| Feb 27, 2014 | Z-1300-2014 | — | terminated | Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the affected lots have a PowerPort Slim titanium implantable port without silicone suture plugs. |
| Dec 6, 2013 | Z-0815-2014 | — | terminated | Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labeling for the device. |
| Dec 6, 2013 | Z-0814-2014 | — | terminated | Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labeling for the device. |
| Jun 10, 2013 | Z-1618-2013 | — | terminated | BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly used during manufacture. The absence of the hydrocolloid strip on the bottom may pose an incremental risk including localized skin irritation. Missing directional arrow may lead to mis-orientation of the StatLock stabilization which may impact the securement of the cathet |
| Feb 21, 2013 | Z-0909-2013 | — | terminated | Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit. |
| Feb 21, 2013 | Z-0910-2013 | — | terminated | Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit. |
| Aug 7, 2012 | Z-2277-2012 | — | terminated | Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters because they were identified with an incorrect expiration date, 03/2015 rather than 10/2013. |
| Feb 16, 2012 | Z-1133-2012 | — | terminated | The end flap label on the kit incorrectly describes the product as "Bard Port" MRI DUAL Implanted Port instead of a "Bard Port MRI Implanted Port" as correctly indicated on the main label of the kit. |
| Aug 30, 2011 | Z-3173-2011 | — | terminated | Implanted port has discrepant product information on package labeling. |
| Jun 21, 2011 | Z-2782-2011 | — | terminated | Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number. |
| Jun 20, 2011 | Z-2783-2011 | — | terminated | Kit label indicates the wrong dimension for an enclosed introducer. |
| May 21, 2011 | Z-2960-2011 | — | terminated | Labeling for drainage kit contained incomplete information. |
| May 21, 2011 | Z-2961-2011 | — | terminated | Labeling for drainage kit contained incomplete information. |
| May 21, 2011 | Z-2962-2011 | — | terminated | Labeling for drainage kit contained incomplete information. |
| May 21, 2011 | Z-2959-2011 | — | terminated | Labeling for drainage kit contained incomplete information. |
| Dec 10, 2010 | Z-0865-2011 | — | terminated | Prepackaged sterile latex gloves beyond their expiration date were packaged in surgical kits. |
| Mar 18, 2010 | Z-1525-2010 | — | terminated | 8F PowerPort stems were mixed with 6F PowerPorts and packaged. |
| Jan 14, 2010 | Z-0861-2010 | — | terminated | After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury. |
| Jan 14, 2010 | Z-0862-2010 | — | terminated | After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury. |
| Apr 6, 2006 | Z-0839-06 | — | terminated | Packaging for some gastrostomy tubes was labeled with incorrect balloon inflation data. An underinflated balloon may cause misplacement, slippage or premature removal of the tube. If an underinflated balloon allows the tube to be placed, or slip into, the stomal tract and not the stomach, there is a risk of infusion of fluids into the peritoneum. This carries the risk of infection. |
| Apr 6, 2006 | Z-0837-06 | — | terminated | Packaging for some gastrostomy tubes was labeled with incorrect balloon inflation data. An underinflated balloon may cause misplacement, slippage or premature removal of the tube. If an underinflated balloon allows the tube to be placed, or slip into, the stomal tract and not the stomach, there is a risk of infusion of fluids into the peritoneum. This carries the risk of infection. |
| Apr 6, 2006 | Z-0836-06 | — | terminated | Packaging for some gastrostomy tubes was labeled with incorrect balloon inflation data. An underinflated balloon may cause misplacement, slippage or premature removal of the tube. If an underinflated balloon allows the tube to be placed, or slip into, the stomal tract and not the stomach, there is a risk of infusion of fluids into the peritoneum. This carries the risk of infection. |
| Apr 6, 2006 | Z-0838-06 | — | terminated | Packaging for some gastrostomy tubes was labeled with incorrect balloon inflation data. An underinflated balloon may cause misplacement, slippage or premature removal of the tube. If an underinflated balloon allows the tube to be placed, or slip into, the stomal tract and not the stomach, there is a risk of infusion of fluids into the peritoneum. This carries the risk of infection. |
| Dec 20, 2005 | Z-0541-06 | — | terminated | Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions. |
| Dec 20, 2005 | Z-0542-06 | — | terminated | Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions. |
| Dec 20, 2005 | Z-0544-06 | — | terminated | Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions. |
| Dec 20, 2005 | Z-0543-06 | — | terminated | Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, indications, contraindications, warnings, precautions, possible complications, and insertion instructions. |
| Nov 3, 2004 | Z-0715-05 | — | terminated | Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile. |
| Nov 3, 2004 | Z-0714-05 | — | terminated | Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile. |
| Nov 3, 2004 | Z-0720-05 | — | terminated | Conductivity gel pouches, labeled as sterile, may not be sterile. |
| Nov 3, 2004 | Z-0717-05 | — | terminated | Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile. |
| Nov 3, 2004 | Z-0716-05 | — | terminated | Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile. |
| Nov 3, 2004 | Z-0719-05 | — | terminated | Conductivity gel pouches, labeled as sterile, may not be sterile. |
| Nov 3, 2004 | Z-0718-05 | — | terminated | Conductivity gel pouches, labeled as sterile, and packaged in various kits may not be sterile. |
| Sep 23, 2003 | Z-0098-04 | — | terminated | Sterility of product is compromised by open seals in packaging. |