American Contract Systems, Inc. Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA01V; b) OR/Anesthesia Central Line Insertion Kit, Kit Number UIAN43L Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA01V; b) OR/Anesthesia Central Line Insertion Kit, Kit Number UIAN43L
Brand
American Contract Systems, Inc.
Lot Codes / Batch Numbers
a) LMHA01V: No UDI/DI, Lot Numbers: 702221, exp. 10/25/223, 654221, exp. 12/12/2023, 954231, exp. 2/15/2024, 903231, exp. 4/7/2024, b) UIAN43L: No UDI/DI, Lot Numbers: 654221, exp. 12/12/2023, 991231, exp. 1/9/2024
Products Sold
a) LMHA01V: No UDI/DI, Lot Numbers: 702221, exp. 10/25/223; 654221, exp. 12/12/2023; 954231, exp. 2/15/2024; 903231, exp. 4/7/2024; b) UIAN43L: No UDI/DI, Lot Numbers: 654221, exp. 12/12/2023; 991231, exp. 1/9/2024
American Contract Systems, Inc. is recalling Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE N due to During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization proces. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026