Recall Z-1690-2022
American Contract Systems, Inc. · initiated June 16, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Various Angiography/Cath Lab packs/trays
Codes / lots: Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRCUSTCATHG,2104091, 911211, 44064504 2) LSRCARDCATHG,2105191, 874211, 14884701 3) LSRCARDCATHG,2106031, 861211, 14887382 4) LSRCFHCATHD,2106151, 839211, 14887387 5) LSRCARDCATHG,2106172, 842211, 14882944 6) LSRCARDCATHG,2106172, 842211, 14887386 7) LSRCUSTCATHG,2106181, 840211, 44251069 8) LSRCFHCATHD,2107102, 810211, 15020227 9) LSRCFHCATHD,2107102, 810211, 15020826 10) LSRCFHCATHD,2107262, 807211, 15020266 11) LSRSPECPROCF,2107262, 803211, 64117654 12) LSRCARDCATHG,2108171, 783211, 44139783 13) LSRCFHCATHD,2109071, 765211, 44376128 14) LSRCFHCATHD,2109071, 765211, 44376127 15) LSRCFHCATHD,2109071, 765211, 44376129 16) LSRCFHCATHD,2109071, 765211, 44376130 17) LSRCUSTCATHG,2109201, 754211, 44373704 18) LSRCFHCATHD,2109271, 740211, 15142078 19) MMCC14D,2104143, 898211, 64033893 20) IHCC03R,2107061, 819211, 44183402 21) HGCL69G,2107202, 803211, 15053840 22) UIRD89AE,2107293, 793211, 44181939 23) AMCL05M,2108131, 777211, 64230198 24) HGCL69G,2108313, 761211, 15062583 25) SHCA31I,2105142, 866211, 44111393-005 26) CXDP36N,2105241, 858211, 14854252-004 27) SHCA31I,2105261, 855211, 44131698-005 28) BLCL72K,2106141…
Reason for recall
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
FDA-determined 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.
Details
- Recall number
- Z-1690-2022
- Initiated
- June 16, 2022
- Product code
- OES – Cardiac Catheterization Kit
- Quantity
- 61 units
- 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
- Recalling firm
- American Contract Systems, Inc., Kansas City, MO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1689-2022 Class II | Various Angiography packs/traysProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1691-2022 Class II | Various Pacemaker Packs, Cardio Thoracic PacksProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1692-2022 Class II | Various PICC Line, Central Line PacksProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1693-2022 Class II | Various ENT PacksProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1694-2022 Class II | Various Laparoscopy PacksProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1695-2022 Class II | Various Cysto PacksProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1696-2022 Class II | Various Port Insertion PacksProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1697-2022 Class II | Breast Abdominoplasty PackProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1698-2022 Class II | Various convenience packsProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1699-2022 Class II | Various convenience packsProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1700-2022 Class II | Various neurology packsProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1701-2022 Class II | Various ob/gyn packsProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1702-2022 Class II | Various hysterectomy, vaginal packsProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1703-2022 Class II | Various C-section packsProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1704-2022 Class II | D&C packProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |
| Z-1705-2022 Class II | Various eye packs, cataract packsProduct was exposed to multiple sterilization cycles without validation for multiple exposures. | 06/16/2022Open, Classified |