UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Reported: January 12, 2022 Initiated: November 22, 2021 #Z-0458-2022
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.
Details
- Recalling Firm
- Uromedica Inc.
- Units Affected
- 18 devices
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.
- Location
- Plymouth, MN
Frequently Asked Questions
What product was recalled? ▼
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.. Recalled by Uromedica Inc.. Units affected: 18 devices.
Why was this product recalled? ▼
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 12, 2022. Severity: Moderate. Recall number: Z-0458-2022.
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