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Sign in to claim this brandAMERICAN CONTRACT SYSTEMS, INC.
US
Last updated May 23, 2026
What AMERICAN CONTRACT SYSTEMS, INC. makes
American Contract Systems, Inc. manufactures single-use, non-medicated general surgical procedure kits designed for various surgical applications. These kits are intended for one-time use in operating room settings and include essential tools and instruments required for specific surgical procedures.
The company’s products are regulated under FDA classification as either Class I or Class II devices, with some falling under the non-classifiable (N) category. These devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. regulatory requirements.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 010334675
Catalogue (21894)
Page 13 of 438| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Acs | SGIV04C | FDA UDI | Class II | Active |
| Acs | HSRS90C | FDA UDI | Class II | Active |
| Acs | UISO44D | FDA UDI | Class I | Active |
| Acs | CDBI93D | FDA UDI | Class II | Active |
| Acs | SLTK16M | FDA UDI | Class II | Active |
| Acs | EFHD60A | FDA UDI | Class I | Active |
| Acs | GBCS14D | FDA UDI | Class II | Active |
| Acs | CMOR73AA | FDA UDI | Class I | Active |
| Acs | CDSL12E | FDA UDI | Class II | Active |
| Acs | SVLC45N | FDA UDI | Class II | Active |
| Acs | LSRLMMIHRTC | FDA UDI | Class II | Active |
| Acs | MHMP78AD | FDA UDI | Class II | Active |
| Acs | SAOB88U | FDA UDI | Class II | Active |
| Acs | MEBS42I | FDA UDI | Class II | Active |
| Acs | CMTN20AL | FDA UDI | Class I | Active |
| Acs | UILD70D | FDA UDI | Class II | Active |
| Acs | PCCY29D | FDA UDI | Class II | Active |
| Acs | BHOH94F | FDA UDI | Class II | Active |
| Acs | AMCS20AC | FDA UDI | Class II | Active |
| Acs | SHHA20E | FDA UDI | Class I | Active |
| Acs | HCNC32D | FDA UDI | Class II | Active |
| Acs | GIDI10F | FDA UDI | Class I | Active |
| Acs | SHMA17E | FDA UDI | Class II | Active |
| Acs | CDCL18E | FDA UDI | Class II | Active |
| Acs | PRSS36C | FDA UDI | Class II | Active |
| Acs | BHAK10D | FDA UDI | Class II | Active |
| Acs | MWOS97J | FDA UDI | Class II | Active |
| Acs | NMLL25U | FDA UDI | Class II | Active |
| Acs | JKMA60H | FDA UDI | Class II | Active |
| Acs | WHAI40D | FDA UDI | Class II | Active |
| Acs | UTBR74U | FDA UDI | Class I | Active |
| Acs | NEEL45E | FDA UDI | Class I | Active |
| Acs | LARP50J | FDA UDI | Class II | Active |
| Acs | MYGY88E | FDA UDI | Class II | Active |
| Acs | HOHP28C | FDA UDI | Class I | Active |
| Acs | CDVA23F | FDA UDI | Class II | Active |
| Acs | EJHP38A | FDA UDI | Class I | Active |
| Acs | FABM01X | FDA UDI | Class II | Active |
| Acs | BRVG05N | FDA UDI | Class II | Active |
| Acs | UDPV21G | FDA UDI | Class II | Active |
| Acs | HOVS19D | FDA UDI | Class II | Active |
| Acs | SFTR00G | FDA UDI | Class I | Active |
| Acs | MPMU11C | FDA UDI | Class II | Active |
| Acs | ICFT45F | FDA UDI | Class II | Active |
| Acs | CACS51E | FDA UDI | Class II | Active |
| Acs | MWTK13X | FDA UDI | Class II | Active |
| Acs | ESCS35B | FDA UDI | Class II | Active |
| Acs | PLCS46D | FDA UDI | Class II | Active |
| Acs | UISN37K | FDA UDI | Class II | Active |
| Acs | BUTK82E | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
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Authorities
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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.
American Contract Systems, Inc. has 190 recall records spanning from December 28, 2016, to March 19, 2026, with statuses recorded as open, classified, or terminated. The reasons cited include concerns about incomplete sterilization, improper handling of components during sterilization processes, incorrect expiration dates, labeling errors, insufficient aeration time, and deviations from sterilization specifications. Some recalls involved third-party products or components, such as syringes from Medline Industries, and the use of FDA-banned substances in powdered surgical gloves.
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 19, 2026 | Z-1981-2026 | — | open, classified | Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism. |
| Sep 4, 2025 | Z-0179-2026 | — | open, classified | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. |
| Sep 4, 2025 | Z-0185-2026 | — | open, classified | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. |
| Sep 4, 2025 | Z-0187-2026 | — | open, classified | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. |
| Sep 4, 2025 | Z-0180-2026 | — | open, classified | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. |
| Sep 4, 2025 | Z-0178-2026 | — | open, classified | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. |
| Sep 4, 2025 | Z-0172-2026 | — | open, classified | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. |
| Sep 4, 2025 | Z-0171-2026 | — | open, classified | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. |
| Sep 4, 2025 | Z-0183-2026 | — | open, classified | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. |
| Sep 4, 2025 | Z-0174-2026 | — | open, classified | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. |
| Sep 4, 2025 | Z-0175-2026 | — | open, classified | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. |
| Sep 4, 2025 | Z-0177-2026 | — | open, classified | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. |
| Sep 4, 2025 | Z-0186-2026 | — | open, classified | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. |
| Sep 4, 2025 | Z-0173-2026 | — | open, classified | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. |
| Sep 4, 2025 | Z-0170-2026 | — | open, classified | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. |
| Sep 4, 2025 | Z-0184-2026 | — | open, classified | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. |
| Sep 4, 2025 | Z-0181-2026 | — | open, classified | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. |
| Sep 4, 2025 | Z-0182-2026 | — | open, classified | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. |
| Sep 4, 2025 | Z-0176-2026 | — | open, classified | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. |
| Jul 14, 2025 | Z-2466-2025 | — | open, classified | During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Jul 14, 2025 | Z-2471-2025 | — | open, classified | During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Jul 14, 2025 | Z-2465-2025 | — | open, classified | During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Jul 14, 2025 | Z-2467-2025 | — | open, classified | During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Jul 14, 2025 | Z-2468-2025 | — | open, classified | During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Jul 14, 2025 | Z-2469-2025 | — | open, classified | During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Jul 14, 2025 | Z-2470-2025 | — | open, classified | During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Jul 14, 2025 | Z-2464-2025 | — | open, classified | During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Jul 14, 2025 | Z-2472-2025 | — | open, classified | During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Apr 21, 2025 | Z-1916-2025 | — | open, classified | Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality that may lead to a delay or prolonged treatment/procedure/therapy. |
| Feb 6, 2025 | Z-1332-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1333-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1349-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1345-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1359-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1356-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1339-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1348-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1358-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1361-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1346-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1331-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1350-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1355-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1347-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1353-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1362-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1354-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1341-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1338-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1352-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1342-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1334-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1357-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1360-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1340-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1335-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1336-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1344-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1337-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1343-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 6, 2025 | Z-1351-2025 | — | open, classified | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. |
| Feb 4, 2025 | Z-1406-2025 | — | open, classified | During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures. |
| Jan 31, 2025 | Z-1425-2025 | — | open, classified | Sterility assurance with procedure trays |
| Jan 31, 2025 | Z-1426-2025 | — | open, classified | Sterility assurance with procedure trays |
| Jan 31, 2025 | Z-1424-2025 | — | open, classified | Sterility assurance with procedure trays |
| Aug 7, 2024 | Z-3230-2024 | — | open, classified | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Aug 7, 2024 | Z-3238-2024 | — | open, classified | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Aug 7, 2024 | Z-3239-2024 | — | open, classified | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Aug 7, 2024 | Z-3227-2024 | — | open, classified | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Aug 7, 2024 | Z-3241-2024 | — | open, classified | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Aug 7, 2024 | Z-3233-2024 | — | open, classified | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Aug 7, 2024 | Z-3242-2024 | — | open, classified | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Aug 7, 2024 | Z-3226-2024 | — | open, classified | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Aug 7, 2024 | Z-3231-2024 | — | open, classified | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Aug 7, 2024 | Z-3229-2024 | — | open, classified | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Aug 7, 2024 | Z-3237-2024 | — | open, classified | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Aug 7, 2024 | Z-3244-2024 | — | open, classified | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Aug 7, 2024 | Z-3232-2024 | — | open, classified | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Aug 7, 2024 | Z-3228-2024 | — | open, classified | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Aug 7, 2024 | Z-3235-2024 | — | open, classified | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Aug 7, 2024 | Z-3240-2024 | — | open, classified | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Aug 7, 2024 | Z-3236-2024 | — | open, classified | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Aug 7, 2024 | Z-3243-2024 | — | open, classified | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| Aug 7, 2024 | Z-3234-2024 | — | open, classified | ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. |
| May 15, 2024 | Z-2274-2024 | — | open, classified | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. |
| May 15, 2024 | Z-2277-2024 | — | open, classified | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. |
| May 15, 2024 | Z-2304-2024 | — | open, classified | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. |
| May 15, 2024 | Z-2283-2024 | — | open, classified | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. |
| May 15, 2024 | Z-2310-2024 | — | open, classified | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. |
| May 15, 2024 | Z-2290-2024 | — | open, classified | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. |
| May 15, 2024 | Z-2284-2024 | — | open, classified | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. |
| May 15, 2024 | Z-2275-2024 | — | open, classified | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. |
| May 15, 2024 | Z-2301-2024 | — | open, classified | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. |
| May 15, 2024 | Z-2299-2024 | — | open, classified | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. |
| May 15, 2024 | Z-2280-2024 | — | open, classified | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. |
| May 15, 2024 | Z-2281-2024 | — | open, classified | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. |
| May 15, 2024 | Z-2307-2024 | — | open, classified | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. |
| May 15, 2024 | Z-2306-2024 | — | open, classified | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. |
| May 15, 2024 | Z-2303-2024 | — | open, classified | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. |
| May 15, 2024 | Z-2308-2024 | — | open, classified | Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012. |