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Recall Observatory FDA recall evidence

Device product

Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK

Z-0181-2026

September 04, 2025

Class II

Product summary

Firm
American Contract Systems Inc.
Event
Event 97659
Status
Ongoing
Classification
Class II
Quantity
32,433 total
Official record key
device-enforcement:Z-0181-2026

Official wording

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.

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

Distribution pattern: US Nationwide distribution in the states of SD, IA, MN, WA, IL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.