FDA Enforcement
Class II
Terminated
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.
Recall: Z-1808-2020
·
Reported May 6, 2020
Enforcement
- Recall Number
- Z-1808-2020
- Event ID
- 85486
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Uromedica Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- May 6, 2020
- Initiation Date
- April 10, 2019
- Classification Date
- April 28, 2020
- Termination Date
- May 18, 2020
- Address
- 1840 Berkshire Ln N, N/A, Plymouth, MN, 55441-3723, United States
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
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 Info
Model 750041, Lot # UM00650
Distribution
Nationwide distribution to the following states: CA, GA, FL, MI, and VA.
Quantity
11 tool sets