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Uromedica Inc. recalls ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel
Recalled May 6, 2020 · FDA recall Z-1808-2020 · Uromedica
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. · FDA Class II
Units
11 tool sets
Sold at
Nationwide distribution to the following states: CA, GA, FL, MI, and VA.
Description
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.
Product
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.
Manufacturer(s)
Uromedica Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →