Plymouth, MN, United States
Uromedica Inc. recalls
2 recalls recorded since 2018, most recently on 22 November 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 22 November 2021
- Terminated
- 11 August 2023
- Reason
- The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0458-2022
- UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Terminated Class II Medical devices
- Recall started
- 10 April 2019
- Terminated
- 18 May 2020
- 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.
- Distribution
- Nationwide distribution to the following states: CA, GA, FL, MI, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1808-2020
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.