FDA-Device2022-01-12Class II
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Uromedica Inc.
Hazard
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Sold states
US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.
Affected count
18 devices
Manufactured in
1840 Berkshire Ln N, N/A, Plymouth, MN, United States
Products
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0458-2022Don't want to check this manually?
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