Gastroenterological and Urological Procedure Kits Recalled for Sterilization Process Failures
American Contract Systems is recalling AHN BIOPSY STERILE procedure kits nationwide because several components were improperly sterilized, potentially compromising device functionality and drug efficacy.
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: This is an FDA Class II recall with theoretical hazards (potential loss of functionality, efficacy, and sterilization residuals). Per the severity rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
American Contract Systems, Inc. is recalling AHN BIOPSY STERILE procedure kits (model AHBP12A) nationwide. The recall affects 95 units with the following lot numbers: 963231 (expiration 1/21/2024), 940231 (expiration 1/21/2024), and 996231 (expiration 2/28/2023). These custom procedural convenience kits are designed for use in gastroenterological and urological procedures.
During an internal investigation, the manufacturer discovered that several components were added to sterilization trays without adequate prior assessment for compatibility with the elevated temperatures and extended duration of the sterilization process. The sterilization process may have compromised these components, potentially resulting in loss of functionality, loss of drug efficacy where applicable, or higher than specified ethylene oxide sterilant residuals.
The affected units were distributed nationwide.
The recalled product
- Product
- Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- functionality-loss
- efficacy-loss
- sterilization-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 (7)
- AHBP12A
- UDI/DI 00191072188229
- Lot Numbers: 963231
- exp. 1/21/2024
- 940231
- 996231
- exp. 2/28/2023
Distribution
Distributed nationwide across the United States.
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