—#216322

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

FDA product code: OJK — Eye Tray
Device class: Class 2
Medical specialty: Ophthalmic
Affected lot / code info: 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

Why it was 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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Firm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers. Consignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.

Recalling firm

Firm: American Contract Systems Inc.
Address: 1601 Se Gateway Dr, Ste 120, Grimes, Iowa 50111-5223

Distribution

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

Timeline

Recall initiated: 2025-09-04
Posted by FDA: 2025-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216322. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.