—#205162

Product

Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit number FDCS01AA; b) C-SECTION PACK, kit number FDCS01AB; c) C-SECTION STERILE PACK, kit number HGCS68J; d) C-SECTION PACK, kit number HICS50H; e) C-SECTION PPS, kit number LLCI66; f) C-Section drape Pack, kit number RBCS12R; g) C-Section, kit number THCS49B; h) C-SECTION PACK (PS 020632), kit number UICS50AG;

FDA product code: OHM — Cesarean Section Tray
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: a) FDCS01AA, UDI/DI 00191072179890, Lot Numbers: 708221, exp. 10/23/2023; 646221, exp. 12/20/2023; b) FDCS01AB, UDI/DI 00191072185273, Lot Numbers: 886231, exp. 4/24/2024; c) HGCS68J, UDI/DI none, Lot Numbers: 702221, exp. 10/22/2023; 654221, exp. 12/12/2023; 960231, exp. 2/9/2024; 903231, exp. 4/7/2024; d) HICS50H, UDI/DI none, Lot Numbers: 909221, exp. 4/1/2023; 835221, exp. 6/14/2023; 755221, exp. 9/2/2023; e) LLCI66, UDI/DI 00191072119025, Lot Numbers: 750221, exp. 9/7/2023; 727221, exp. 9/30/2023; 678221, exp. 11/9/2023; 994231, exp. 11/9/2023; 948231, exp. 11/9/2023; 926231, exp. 11/9/2023; f) RBCS12R, UDI/DI 00191072131812, Lot Numbers: 770221, exp. 8/18/2023; 695221, exp. 11/1/2023; g) THCS49B, UDI/DI 00191072153357, Lot Numbers: 770221, exp. 8/18/2023; h) UICS50AG, UDI/DI none, Lot Numbers: 679221, exp. 11/17/2023; 946231, exp. 2/23/2024; 876231, exp. 5/4/2024;

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: American Contract Systems, Inc.
Address: 7802 E Telecom Pkwy, Temple Terrace, Florida 33637-0928

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2023-11-29
Posted by FDA: 2024-01-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205162. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.