Recall Z-0458-2022
Uromedica Inc. · initiated November 22, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Codes / lots: Lot numbers UM00794 and UM00817, UDI 00180668000106
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: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0458-2022
- Initiated
- November 22, 2021
- Terminated
- August 11, 2023
- Product code
- EZY – Device, Incontinence, Mechanical/Hydraulic
- Quantity
- 18 devices
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.
- Recalling firm
- Uromedica Inc., Plymouth, MN