Home / Recalls / Uromedica Inc. / Z-1808-2020

Z-1808-2020 Class II Terminated

Recalled by Uromedica Inc. — Plymouth, MN

Recall Details

Product Type: Devices
Report Date: May 6, 2020
Initiation Date: April 10, 2019
Termination Date: May 18, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 11 tool sets

Product Description

ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.

Reason for Recall

Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths.

Distribution Pattern

Nationwide distribution to the following states: CA, GA, FL, MI, and VA.

Code Information

Model 750041, Lot # UM00650