Custom OB/GYN Procedural Kits Recalled for Sterilization Process Failure
American Contract Systems recalled 144 custom OB/GYN procedural kits after discovering components were sterilized without proper documentation, potentially losing functionality or efficacy. Affected units were distributed nationwide.
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 with no reported illnesses. The potential for loss of functionality and compromised drug efficacy in surgical instruments represents a risk-of-harm product where injury has not yet been reported.
Plain-English summary
American Contract Systems, Inc. is recalling 144 custom procedural convenience kits and trays for obstetrical and gynecological use. The recalled products include LavH (kit number BBLV21C) and LAP HYST 247540 (kit number BFHY75U), distributed nationwide.
During an internal investigation, American Contract Systems identified that several components had been attached to the ACS trays and subjected to the company's standard sterilization process. However, there was no supporting documentation verifying that these components were assessed for suitability to elevated temperatures and the extended sterilization procedure.
As a result, the affected components may have experienced loss or lack of functionality, reduced drug efficacy if applicable, and may contain higher than specified levels of ethylene oxide residuals from the sterilization process.
Healthcare facilities currently using these kits should immediately discontinue use and contact American Contract Systems regarding replacement or disposal options.
The recalled product
- Product
- Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST 247540, kit number BFHY75U
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- sterilization-failure
- loss-of-functionality
- eo-residuals
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) BBLV21C
- UDI/DI none
- Lot Numbers: 686221
- exp. 11/10/2023
- 791221
- exp. 7/28/2023
- 841221
- exp. 6/8/2023
- b) BFHY75U
- UDI/DI 00191072169839
- Lot Numbers: 878231
- exp. 5/2/2024
- 933231
- exp. 3/8/2024
- 987231
- exp. 11/30/2023
- 659221
- exp. 12/7/2023
- 689221
- exp. 11/7/2023
Distribution
Distributed nationwide across the United States.
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