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Custom procedural convenience kits and trays, Obstetrical &… recallZ-0830-2024 · American Contract Systems, Inc. · initiated Nov 29, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from American Contract Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Process control

What the company is doing

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 [email protected].

Recall details

Recall number
Z-0830-2024
Status
Open, Classified
Initiated by the company
Nov 29, 2023
Posted by the FDA
Jan 26, 2024
Recalling firm
American Contract Systems, Inc.
Quantity
1818 units
Product code
OHM
Distribution
US Nationwide distribution.

Product description

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;

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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;

Devices named in this recall

5 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 93656).

Sources and updates

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