American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit
Recall
- Recall Number
- Z-2519-2024
- Event Number
- 94908
- Firm
- American Contract Systems, Inc.
- FEI Number
- 3003419114
- Product Code
- FDE
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- May 6, 2024
- Posted
- August 7, 2024
- Address
- 2610 Ne Industrial Dr, Ste 220, Kansas City, MO, 64117-2648
Description
American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit
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
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.
US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.
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