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Open, Classified

American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit

FDA Recall Z-2519-2024 · Posted 2024-08-07

Recall StatusOpen, Classified
Product CodeFDE
Date Initiated2024-05-06
Product Quantity120

Reason for Recall

Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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