Recall Z-1698-2022
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 convenience packs
Codes / lots: Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRICUMXBARB, 2104091, 905211, 14531603 2) LSRBASICPACD, 2104091, 90921+A3:A1061, 14798924 3) LSRCFBVIIIPKE, 2104091, 904211, 14806477 4) LSRBASICPACD, 2105101, 881211, 14880418 5) LSRMAJBASINC, 2106082, 860211, 44252207 6) LSRMAJBASINC, 2106082, 860211, 44251930 7) LSRLATEXTUBA, 2106021, 855211, 63157124 8) LSRULTRASNDE, 2106021, 854211, 63157124 9) LSRGCMAJA, 2106082, 852211, 63989104 10) LSRBASICPACD, 2107151, 812211, 15020877 11) LSRBASICPACD, 2107262, 809211, 44540501 12) LSRBASICPACD, 2107262, 809211, 43967223 13) LSRSMTRAMAA, 2107262, 799211, 64117655 14) LSRBASICPACD, 2108042, 791211, 44140770 15) LSRLMMAJLAPI, 2108251, 779211, 64119586 16) LSRMAJBASINC, 2108251, 775211, 44376071 17) LSRBASICPACD, 2109071, 771211, 15142869 18) LSRBASICPACD, 2109071, 771211, 15142870 19) LSRGENLAPD, 2109071, 764211, 44376119 20) LSRGENLAPD, 2109071, 764211, 44376120 21) LSRULTRASNDE, 2109162, 754211, 64318297 22) LSRCFHSBASD, 2109271, 742211, 44373955 23) LSRCFHSBASD, 2109271, 742211, 44373956 24) LSRMAJBASINC, 2109271, 740211, 44373122 25) LSRBASICPACD, 2109271, 740211, 15142071 26) CFLA39E, 2104072, 904211, 64022736 27)…
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-1698-2022
- Initiated
- June 16, 2022
- Product code
- LRO – General Surgery Tray
- Quantity
- 116
- 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-1690-2022 Class II | Various Angiography/Cath Lab 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-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 |