Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) DAVINCI GYN PACK, kit number HHDV17; d) KIT, GYNE ROBOTIC, kit number MMGR44D; e) KIT, MAJOR LITHOTOMY, kit number MMJL16E; f) GYN PACK, kit number SMGY46; g) Lithotomy Pack, kit number THLH71C; h) ASC HYSTEROSCOPY PACK (PS 020634), kit number UIHY16AA; i) GYN LAPAROSCOPY HPES, kit number WELP67C; j) GYN LAPAROSCOPY HPES, kit number WELP67C-01; k) GYN LAPAROSCOPY HPES, kit number WELP67C-02
This recall is currently active, issued January 26, 2024. It was issued by American Contract Systems, Inc..
- Company
- American Contract Systems, Inc.
- Recall Initiated
- November 29, 2023
- Posted
- January 26, 2024
- Recall Number
- Z-0828-2024
- Quantity
- 1020 units
- Firm Location
- Temple Terrace, FL
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution.
Lot / Code Info
a) AGLP52L, UDI/DI 00191072144119, Lot Numbers: 933231, exp. 3/8/2024; 942231, exp. 2/27/2024; 947231, exp. 2/22/2024; 966231, exp. 2/3/2024; 980231, exp. 1/20/2024; 681221, exp. 11/15/2023; 707221, exp. 10/20/2023; b) HGOB98G, UDI/DI none, Lot Numbers: 667221, exp. 11/29/2023; 977231, exp. 1/23/2024; 952231, exp. 1/31/2024; 896231, exp. 1/31/2024; c) HHDV17, UDI/DI 00191072170125, Lot Numbers: 766221, exp. 8/22/2023; 731221, exp. 9/26/2023; 682221, exp. 11/14/2023; 638221, exp. 12/28/2023; 946231, exp. 2/23/2024; d) MMGR44D, UDI/DI none, Lot Numbers: 709221, exp. 10/18/2023; 650221, exp. 12/16/2023; 891231, exp. 4/19/2024; e) MMJL16E, UDI/DI none, Lot Numbers: 989231, exp. 1/11/2024; 920231, exp. 3/21/2024; f) SMGY46, UDI/DI 00191072188458, Lot Numbers: 961231, exp. 2/8/2024; g) THLH71C, UDI/DI 00191072155108, Lot Numbers: 756221, exp. 9/1/2023; 708221, exp. 10/19/2023; h) UIHY16AA, UDI/DI none, Lot Numbers: 931231, exp. 3/10/2024; 896231, exp. 4/14/2024; i) WELP67C, UDI/DI 00191072173676, Lot Numbers: 751221, exp. 9/6/2023; 681221, exp. 9/13/2023; j) WELP67C-01, UDI/DI 00191072173676, Lot Numbers: 720221, exp. 9/21/2023; k) WELP67C-02, UDI/DI 00191072173676, Lot Numbers: 643221, exp. 9/13/2023
Root 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.