American Contract Systems Special Procedure Pack convenience kit
FDA device recall Z-2520-2024 · posted 2024-08-07 · Open, Classified
Recall details
- Recalling firm
- American Contract Systems, Inc.
- 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
- Action taken
- 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
- Status
- Open, Classified
- Product code
- OEQ
- Quantity affected
- 112
- Distribution
- US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.
- Date initiated
- 2024-05-06
- Date posted
- 2024-08-07
- Location
- Kansas City, MO
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