Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C;

FDA device recall Z-0831-2024 · posted 2024-01-26 · Open, Classified

Recall details

Recalling firm

American Contract Systems, Inc.

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.

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.

Root cause

Process control

Status

Open, Classified

Product code

OJF

Quantity affected

144 units

Distribution

US Nationwide distribution.

Date initiated

2023-11-29

Date posted

2024-01-26

Location

Temple Terrace, FL