Device 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.
Z-1808-2020
Product summary
- Firm
- Uromedica Inc.
- Event
- Event 85486
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 tool sets
- Official record key
device-enforcement:Z-1808-2020
Official wording
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.
Code information: Model 750041, Lot # UM00650
Distribution pattern: Nationwide distribution to the following states: CA, GA, FL, MI, and VA.
Derived failure modes
-
Unknown
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.