Various C-section packs
- Company
- American Contract Systems, Inc.
- Recall Initiated
- June 16, 2022
- Recall Number
- Z-1703-2022
- Quantity
- 24 units
- Firm Location
- Kansas City, MO
Reason for Recall
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Distribution
Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX
Lot / Code Info
Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRHPCSECTB, 2106301, 826211, 64124711 2) FHCP08U, 2107143, 807211, 64166455 3) LMSE38N, 2108202, 770211, 64231900 4) CFCS39G, 2108243, 768211, 64232041 5) IHCS29AA, 2109272, 733211, 64214921 6) CXCS92U, 2106191, 830211, 64071586-006 7) BHCS88D, 2104163, 897211, 64072275-006 8) BHCS88D, 2104163, 897211, 64072274-006 9) BHCS88D, 2104163, 897211, 64072275-006 10) BHCS88D, 2105151, 869211, 64067191-006 11) BHCS88D, 2106091, 848211, 64045555-006 12) BHCS88D, 2106232, 835211, 64091025-006 13) BHCS88D, 2106232, 835211, 64091024-006 14) BHCS88D, 2107061, 835211, 64090343-006 15) BHCS88D, 2107132, 811211, 64089826-006 16) BHCS88D, 2107132, 811211, 64089827-006 17) BHCS88D, 2107132, 811211, 64089828-006 18) BHCS88D, 2107161, 806211, 64088821-006 19) BHCS88D, 2107161, 806211, 64088822-006 20) BHCS88D, 2108171, 777211, 64092742-006 21) BHCS88D, 2109072, 758211, 63997845-006 22) BHCS88D, 2109072, 758211, 63997846-006 23) SWCS92K, 2107151, 811211, 64129480-006 24) SSCS25D, 2108171, 774211, 64139013-006
Root Cause
Process change control
Action Taken
The recalling firm began notifying customers of the recall beginning June 13, 2022. Customer notification was initially made via email and an "Urgent Medical Device Recall" letter dated June 16, 2022. Customers are asked to review inventory and segregate affected product, which should be identified with the Bag Serial Number. Affected product should be destroyed, with evidence of destruction provided back to the recalling firm. A Field Action Response Form should be completed and returned to angela.bunn@owens-minor.com as soon as possible, even if the customer has no inventory. If you have any questions, please call 816-920-5846.