Agency classClass IIOur severity:High FDA (Devices)·Z-0823-2024·Announced 2024-02-07

Urological procedural kits recalled due to sterilization defects

American Contract Systems recalled 1,031 urological procedure kits nationwide due to sterilization process defects. Components may have damaged functionality, reduced drug efficacy, or elevated 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: This is an FDA Class II recall of surgical instruments where components may have loss of functionality and elevated sterilization residuals. Although no illnesses or injuries have been reported, the potential for harm in urological surgical procedures justifies a High severity rating.

Plain-English summary

American Contract Systems, Inc. is recalling 1,031 custom urological procedural convenience kits and trays distributed nationwide. The affected products are the UROLOGY DAVINCI PACK (kit number HGUR87G), CYSTO PACK (kit number LVCY20), and URO ROBOTIC PACK (kit number LVUR44).

During an internal investigation, the manufacturer identified that certain components were added to the trays without documented assessment of whether they could safely withstand the sterilization process. These components were subjected to elevated temperatures for an extended period during sterilization. As a result, the affected components may have experienced loss of functionality, loss of drug efficacy where applicable, or may contain higher than specified ethylene oxide residuals.

The recall affects all 1,031 units of the three kit types with identified lot numbers distributed across the United States.

The recalled product

Product: Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G; b) CYSTO PACK, kit number LVCY20; c) URO ROBOTIC PACK, kit number LVUR44;
Manufacturer: American Contract Systems, Inc.
Category: Medical Device — Urological Surgical Instruments
Hazard: loss-of-functionality
loss-of-drug-efficacy
eo-residuals
Affected units: 1,031

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) HGUR87G
UDI/DI none
Lot Numbers: 751221
exp. 9/6/2023
651221
exp. 12/15/2023
973231
exp. 1/27/2024
939231
exp. 3/2/2024
b) LVCY20
UDI/DI 00191072117991
Lot Numbers: 769221
exp. 8/19/2024
727221
exp. 9/30/2024
701221
exp. 10/26/2023
643221
exp. 12/23/2023

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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