Reported Feb 7, 2024 · Ongoing
Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack, kit…
American Contract Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Contract Systems, Inc. · 7802 E Telecom Pkwy · Temple Terrace, FL · 33637-0928
Is this the product you have?
- Custom procedural convenience kits and trays, general & plastic surgery
- labeled asa) Breast Plastics Pack, kit number BBPL20D; b) MINOR PLASTIC, kit number WPMP16H
- Lot codes and dates
- a) BBPL20D
- Lot Codes
862221exp. 5/18/2023688221exp. 5/31/2023756221exp. 9/1/2023782221exp. 8/6/2023b) WPMP16H
- Lot Codes
904231exp. 4/6/2024966231exp. 2/3/2024650221exp. 12/16/2023708221exp. 10/19/2023805221exp. 7/14/2023888221exp. 4/22/2023867221exp. 5/13/2023
- Amount recalled
- 112 units
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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