American Contract Systems Inc: Device Recall

Recall #Z-1341-2025 · 02/06/2025

Class II: Risk

Recall Details

Recall Number: Z-1341-2025
Classification: Class II
Product Type: Device
Recalling Firm: American Contract Systems Inc
Status: Ongoing
Date Initiated: 02/06/2025
Location: Tiffin, OH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 54 kits

Reason for Recall

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

Product Description

BORN ON ARRIVAL KIT , Model No LLBN11B

Distribution Pattern

US Nationwide distribution in the state of OH.

Other Recalls by American Contract Systems Inc

Class II: Risk 09/04/2025

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.
Class II: Risk 09/04/2025

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.
Class II: Risk 09/04/2025

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.
Class II: Risk 09/04/2025

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.
Class II: Risk 09/04/2025

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.

View all recalls by American Contract Systems Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.