Custom Surgical Procedure Kits Recalled for Improper Sterilization Assessment
American Contract Systems is recalling 3,196 custom surgical procedure kits because sterilized components lacked documented suitability assessment. The components may have lost functionality or accumulated excessive sterilization residuals.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of surgical procedure kits with potentially compromised components that lack sterilization suitability documentation. No illnesses or injuries have been reported, meeting the rubric criterion for High: risk-of-harm products where injury has not yet been reported.
Plain-English summary
American Contract Systems, Inc. is recalling 3,196 custom surgical procedure kits used for gastroenterological and urological procedures. These kits were distributed nationwide.
During an internal investigation, American Contract Systems identified that several components were "piggybacked" (added) to ACS trays and exposed to the ACS sterilization process. The manufacturer found no supporting documentation demonstrating that these piggybacked components were assessed for suitability to exposure to elevated temperatures for extended periods. As a result, the affected components may have experienced loss or lack of functionality, loss of drug efficacy (if applicable), or accumulated higher-than-specified ethylene oxide residuals.
Medical facilities that received these products should identify affected kits using the kit numbers and lot numbers listed by the FDA. Individuals with questions about whether their facility received recalled products should contact American Contract Systems or the FDA at recall number Z-0822-2024.
The recalled product
- Product
- Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, kit number BFLC02AD; d) GENERAL LAPAROSCOPY PACK, kit numbe
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- loss-of-functionality
- sterilization-residuals
- loss-of-efficacy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) AGKD50L
- UDI/DI 00191072141156
- Lot Numbers: 905231
- exp. 4/5/2024
- 638221
- exp. 12/28/2023
- 689221
- exp. 5/21/2023
- b) ANPR34S
- UDI/DI 00191072171351
- Lot Numbers: 721221
- exp. 10/6/2023
- 879231
- exp. 5/1/2024
- 896231
- exp. 4/14/2024
- 927231
- exp. 3/14/2024
- 956231
- exp. 2/13/2024
Distribution
Distributed nationwide across the United States.
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