Custom procedural convenience kits and trays recall
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, kit number HILD52F; b) LABOR &…
Why was Custom procedural convenience kits and trays recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, kit number HILD52F; b) LABOR &…
- Recalling firm
- American Contract Systems, Inc.
- Quantity
- 114 units
- Distribution
- US Nationwide distribution.
- Recall date
- February 7, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)