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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 3,196
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.
Part of a larger recall action
This product is one of 18 recalled by American Contract Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 18 products in this recall →Related recalls
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