American Contract Systems Inc.: Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- American Contract Systems Inc.
- Product
- Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- Recall initiated
- 2025-09-04
- Code info
- FHCP08Y UDI-DI 191072232724 Lot 8216211 Bag serial number 68258296; HICS50I UDI-DI 191072212351 Lot 8161711 Bag serial number 68273637; HSCB90B UDI-DI 191072141606 Lot 8083511 Bag serial numbers 47506618 47508489 * If bag serial number is listed as "N/A", then whole lot is affected
- Product quantity
- 32,433 total
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Grimes
- State
- IA
- Country
- United States
- Event id
- 97659
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