Recall Z-0181-2026— American Contract Systems Inc.
Class II · Ongoing
Class II FDA medical device recall by American Contract Systems Inc., initiated 2025-09-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK. Reason: 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..
- Recalling firm
- American Contract Systems Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-04
- Firm location
- Grimes, IA, United States
Product description
Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.