FDAApril 10, 2019device
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 recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
uromedica
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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