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U.S. Department of Health and Human Services

Class 2 Device Recall UROMEDICA

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  Class 2 Device Recall UROMEDICA see related information
Date Initiated by Firm November 22, 2021
Create Date January 05, 2022
Recall Status1 Terminated 3 on August 11, 2023
Recall Number Z-0458-2022
Recall Event ID 89184
PMA Number P130018 
Product Classification Device, incontinence, mechanical/hydraulic - Product Code EZY
Product UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Code Information Lot numbers UM00794 and UM00817, UDI 00180668000106
Recalling Firm/
Manufacturer		 Uromedica Inc.
1840 Berkshire Ln N
Plymouth MN 55441-3723
For Additional Information Contact Mr. Robert W. McLain
763-694-9880
Manufacturer Reason
for Recall		 The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Letters dated 11/22/2021 were issued via email to the consignees explaining the reason for recall. The consignee is requested to identify and remove the affected u-channel sheath and sharp trocar from circulation at their facility. The consignee will be contacted by a Uromedica representative who will schedule an in-person visit and collect the affected U-channel sheath and sharp trocar. Once the instruments have been removed from the facility, replacement instruments will be provided.
Quantity in Commerce 18 devices
Distribution US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = EZY and Original Applicant = UROMEDICA INC
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