—#208764

Product

American Contract Systems Cataract Pack convenience kit

FDA product code: OJK — Eye Tray
Device class: Class 2
Medical specialty: Ophthalmic
Affected lot / code info: UDI-DI 00191072188762; Lot 988241; Exp. Date 1/12/2025.

Why it was recalled

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The recalling firm issued recall letters on and dated 5/6/2024 via email or overnight mail. The letter explained the event details, product involved, risk to health, and actions to take. The actions included (1) review your inventory and segregate and quarantine all affected trays. If any of the trays have been further distributed, ensure all end users are notified and maintain records of effectiveness; (2) discard all affected kits and document on the enclosed Response Form; and (3) complete the enclosed Response Form and return it as soon as possible.

Recalling firm

Firm: American Contract Systems, Inc.
Address: 2610 Ne Industrial Dr, Ste 220, Kansas City, Missouri 64117-2648

Distribution

Distribution pattern: US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.

Timeline

Recall initiated: 2024-05-06
Posted by FDA: 2024-08-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208764. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.