Z-0830-2024Class II

Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK...

Name: Z-0830-2024 Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK...
Creator: American Contract Systems, Inc.
Published: 2023-11-29
License: https://open.fda.gov/license/

American Contract Systems, Inc. / initiated 2023-11-29 / Open, Classified / root cause: manufacturing process

FDA source

American Contract Systems, Inc. began a recall of Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit number FDCS01AA; b) C-SECTION PACK, kit... on 2023-11-29. FDA classified it as Class II and gives the reason as "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"...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0830-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-29
Posted: 2024-01-26
Recalling firm: American Contract Systems, Inc.
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;
Product code: OHM Cesarean Section Tray
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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].
Quantity in commerce: 1818 units
Distribution: US Nationwide distribution.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0830-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0816-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26
Z-0817-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26
Z-0818-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26
Z-0819-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26
Z-0820-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26
Z-0821-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26
Z-0822-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26
Z-0823-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26
Z-0824-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26
Z-0825-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26
Z-0826-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26
Z-0827-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26
Z-0828-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26
Z-0829-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26
Z-0830-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26
Z-0831-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26
Z-0832-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26
Z-0833-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-26

Product code OHM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)