Device product
Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 PERP25AQ PEI RETINAL PACK-206025 RFEY50AC EYE PACK-206026 UIVT47AS VITRECTOMY SUPPLY
Z-0185-2026
Product summary
- Event
- Event 97659
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 32,433 total
- Official record key
device-enforcement:Z-0185-2026
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: BFCT04X UDI-DI 191072225955 Lot 7992111 bag serial number N/A; CMEY17AI UDI-DI 191072211514 lot 8082511 bag serial numbers 17390960 17390970 17391031; PERP25AQ UDI-DI 191072199720 lot 8078511 bag serial number 17507000; RFEY50AC UDI-DI 191072202918 lot 8048811 bag serial number 17483686; UIVT47AS UDI-DI 191072224569 lot 7969711 bag serial number N/A * 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
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.