American Contract Systems Inc.: Device Recall
Recall #Z-0177-2026 · 09/04/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0177-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- American Contract Systems Inc.
- Status
- Ongoing
- Date Initiated
- 09/04/2025
- Location
- Grimes, IA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,433 total
Reason for Recall
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.
Product Description
Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT
Distribution Pattern
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
Other Recalls by American Contract Systems Inc.
- Class II: Risk 09/04/2025
- Class II: Risk 09/04/2025
- Class II: Risk 09/04/2025
- Class II: Risk 09/04/2025
- Class II: Risk 09/04/2025
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.