Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, kit number HILD52F; b) LABOR & DELIVERY PACK, kit number HILD52G

Reason: 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.

Code information: a) HILD52F, UDI/DI none, Lot Numbers: 846221, exp. 6/3/2023; 807221, exp. 7/12/2023; 959231, exp. 11/30/2023; b) HILD52G, UDI/DI none, Lot Numbers: 885231, exp. 4/25/2024

Distribution pattern: US Nationwide distribution.