FDA-Device2020-05-06Class II
ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.
Uromedica Inc.
Hazard
Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths.
Sold states
Nationwide distribution to the following states: CA, GA, FL, MI, and VA.
Affected count
11 tool sets
Manufactured in
1840 Berkshire Ln N, N/A, Plymouth, MN, United States
Products
ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1808-2020Don't want to check this manually?
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