Recall Z-1808-2020— Uromedica Inc.
Class II · Terminated
Class II FDA medical device recall by Uromedica Inc., initiated 2019-04-10, terminated 2020-05-18. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Uromedica Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-04-10
- Terminated
- 2020-05-18
- Firm location
- Plymouth, MN, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.