Recall Z-0827-2024
American Contract Systems, Inc. · initiated November 29, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; b) ADULT CRANIOTOMY PACK, kit number LLCR99; c) LAMINECTOMY PACK, kit number LLLC26; d) KIT, CRANIOTOMY, kit number MMCR11J; e) KIT, NEURO SPINE, kit number MMNS20H; f) IR NEURO PACK, kit number OSIN77; g) NEURO SAH, kit number SANE32H; h) NEURO SAH, kit number SANE32I; i) S78FCH CRANI PACK (PS 132432), kit number UICR10U; j) CRANI PACK (PS039498), kit number UICR33AW; k) Laminectomy, kit number UILM77AR; l) DIAGNOSTIC NEURO IR TRAY, kit number WENE21D; m) DIAGNOSTIC NEURO IR TRAY, kit number WENE21F; n) DIAGNOSTIC NEURO IR TRAY, kit number WENE21H; o) DIAGNOSTIC NEURO IR TRAY, kit number WENE21H-01; p) NEURO IR TRAY, kit number WENI56F; q) NEURO IR TRAY, kit number WENI56H; r) NEURO IR TRAY, kit number WENI56H-01
Codes / lots: a) AGNE20J, UDI/DI 00191072183187, Lot Numbers: 934231, exp. 10/30/2023; 900231, exp. 4/10/2024; 990231, exp. 1/10/2024; 687221, exp. 11/9/2023; 720221, exp. 10/7/2023; 757221, exp. 8/31/2023; 870221, exp. 5/10/2023; 702221, exp. 10/25/2023; 795221, exp. 7/24/2023; b) LLCR99, UDI/DI 00191072162755, Lot Numbers: 756221, exp. 9/1/2023; 720221, exp. 10/7/2023; 654221, exp. 12/12/2023; 949231, exp. 2/20/2024; c) LLLC26, UDI/DI 00191072171900, Lot Numbers: 749221, exp. 9/8/2023; 695221, exp. 11/1/2023; 997231, exp. 1/3/2024; 920231, exp. 3/21/2024; d) MMCR11J, UDI/DI none, Lot Numbers: 744221, exp. 9/13/2023; 939231, exp. 3/2/2024; 876231, exp. 5/4/2024; e) MMNS20H, UDI/DI none, Lot Numbers: 963231, exp. 2/6/2024; 959231, exp. 2/10/2024; f) OSIN77, UDI/DI 00191072170705, Lot Numbers: 780221, exp. 8/8/2023; 728221, exp. 9/29/2023; 668221, exp. 11/28/2023; 991231, exp. 1/9/2024, 960231, exp. 2/9/2024; 939231, exp. 3/2/2024; UDI/DI 00191072190031, Lot Numbers: 912231, exp. 3/29/2024; 903231, exp. 4/7/2024; g) SANE32H, UDI/DI none, Lot Numbers: 838221, exp. 6/11/2023; 889221, exp. 4/21/2023; h) SANE32I, UDI/DI none, Lot Numbers: 673221, exp. 11/23/2023; 730221, exp. 9/27/2023; 784221…
Reason for recall
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.
FDA-determined cause: Process control
Action taken
Owens & Minor issued an URGENT: MEDICAL DEVICE CORRECTION notice to it consignees on 11/29/2023 via email. Then notice explained the problem, risk to health, and requested the following actions be taken: If you received any of the batches/lots identified, please segregate and quarantine all affected product. Add warning labels to all kits/cases impacted: A labeling template is enclosed for printing warning labels which should be affixed to all affected product in inventory. This label should be affixed to each affected kit and case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. " Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. " Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified of this field correction and maintain records of effectiveness. Report any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com.
Details
- Recall number
- Z-0827-2024
- Initiated
- November 29, 2023
- Posted by FDA
- January 26, 2024
- Product code
- OJG – Neurological Tray
- Quantity
- 2717 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- American Contract Systems, Inc., Temple Terrace, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0816-2024 Class II | Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0817-2024 Class II | Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0818-2024 Class II | Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0819-2024 Class II | Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0820-2024 Class II | Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0821-2024 Class II | Custom procedural convenience kits and trays, gastroenterological & urological, labeled…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0822-2024 Class II | Custom procedural convenience kits and trays, gastroenterological & urological, labeled…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0823-2024 Class II | Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0824-2024 Class II | Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a)…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0825-2024 Class II | Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a)…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0826-2024 Class II | Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0828-2024 Class II | Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0829-2024 Class II | Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0830-2024 Class II | Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0831-2024 Class II | Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0832-2024 Class II | Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |
| Z-0833-2024 Class II | Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP…During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and… | 11/29/2023Open, Classified |