American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit
- Company
- American Contract Systems, Inc.
- Recall Initiated
- May 6, 2024
- Posted
- August 7, 2024
- Recall Number
- Z-2521-2024
- Quantity
- 15 kits
- Firm Location
- Kansas City, MO
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
Distribution
US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.
Lot / Code Info
(1) Model No ALEX17A; UDI-DI 00191072201546, Lot 983241;Exp. Date 1/17/2025; (2) Model No AKHD97A; UDI-DI 00191072201126; Lot 988241;Exp. Date 1/12/2025; (3) Model No CETJ13O; UDI-DI 00191072202017; Lot 989241;Exp. Date 1/11/2025.
Root Cause
Under Investigation by firm
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.