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
Published February 7, 2024 · Recall initiated: November 29, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- American Contract Systems, Inc.
- Distributor
- US Nationwide distribution.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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