Z-0181-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 22, 2025
- Initiation Date
- September 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,433 total
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.
Distribution Pattern
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
Code Information
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