Medical convenience kits recall
Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 CMEY17AI EYE…
Why was Medical convenience kits recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 CMEY17AI EYE…
- Recalling firm
- American Contract Systems Inc.
- Quantity
- 32,433 total
- Distribution
- US Nationwide distribution in the states of SD, IA, MN, WA, IL.
- Recall date
- October 22, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)