High FDA (Devices)·Z-0822-2024·Announced 2024-02-07

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.
Category: Medical Device — Surgical Instruments
Hazard: loss-of-functionality
sterilization-residuals
loss-of-efficacy
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 →

Same manufacturer · American Contract Systems, Inc.

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