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.
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 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.
- Hazard
- loss-of-functionality
- loss-of-drug-efficacy
- 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) 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.
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