Agency classClass IIOur severity:High FDA (Devices)·Z-0821-2024·Announced 2024-02-07

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.

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: 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.
Category: Medical Device — Biopsy and Procedural Convenience Kits
Hazard: functionality-loss
efficacy-loss
sterilization-residuals
Affected units: 95

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.

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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