Recall Z-0458-2022— Uromedica Inc.
Class II · Terminated
Class II FDA medical device recall by Uromedica Inc., initiated 2021-11-22, terminated 2023-08-11. FDA's recall record names no specific 510(k) clearance for this event. Product: UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.. Reason: The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure..
- Recalling firm
- Uromedica Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-11-22
- Terminated
- 2023-08-11
- Firm location
- Plymouth, MN, United States
Product description
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.