Endovascular AAA Pack, ESED52B; Medical convenience kit
- Company
- American Contract Systems, Inc.
- Recall Initiated
- August 7, 2024
- Posted
- September 24, 2024
- Recall Number
- Z-3228-2024
- Quantity
- 360 units
- Firm Location
- Kansas City, MO
Reason for Recall
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Distribution
US Nationwide distribution in the states of MO, MN, MA, OH, NE.
Lot / Code Info
UDI-DI: 00191072198402; Lot: 2405152; Exp: 05/15/2025
Root Cause
Under Investigation by firm
Action Taken
Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 08/07/2024 via email. The notice explained the issue, potential risk to health, and requested the following actions be taken: " -Please review your inventory, and segregate and quarantine all affected Trays. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. - Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 08/07/2024 via email. The notice explained the issue, potential risk to health, and requested the following actions be taken: " Please review your inventory, and segregate and quarantine all affected Trays. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. - Discard all affected kits and document on the enclosed Response Form."