Uromedica Recalls ProACT Implantation Instrument Sets Due to Sheath Defects
Uromedica Inc. is recalling 11 ProACT Implantation Instrument Sets because defective U-channel sheaths may damage ProACT implant devices during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that poses a risk of harm (damage to implant devices) but the source text does not report any injuries, illnesses, or fatalities, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Uromedica Inc. is recalling 11 ProACT Implantation Instrument Sets, Model 750041, Lot # UM00650. These reusable, steam-sterilizable surgical instrument sets consist of a U-Channel Sheath used to introduce ProACT balloon implants. The recall is due to a potential issue with the manufacture and inspection of the U-channel sheaths.
The affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when the implants pass through the sheaths. The recall covers nationwide distribution to California, Georgia, Florida, Michigan, and Virginia.
Healthcare providers and facilities that have received these specific instrument sets should stop using them and contact Uromedica Inc. for instructions on how to return the affected units.
The recalled product
- 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.
- Manufacturer
- Uromedica Inc.
- Hazard
- Affected units
- 11
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model 750041
- Lot # UM00650
Distribution
Related recalls
Same manufacturer · Uromedica Inc.
See all →- HighUROMEDICA Implantation Instrument Sheath May Damage ProACT Implants
FDA (Devices) · 2022-01-12
Same hazard · device damage
See all →- HighRENASYS EDGE 800ML Canister Recalled for Carbon Filter Damage Risk
FDA (Devices) · 2024-04-24
- SevereNimbus II Infusion Pump Systems Recalled for Multiple Potential Device Failures
FDA (Devices) · 2024-04-03
- HighBaxter peritoneal dialysis transfer sets may crack or leak with certain cleaners
FDA (Devices) · 2022-02-16
- HighCorin Unity Knee Augments Recalled Due to Packaging Damage and Sterility Loss
FDA (Devices) · 2021-10-06
- ModerateNovo Nordisk Recalls Saxenda Injection Samples Due to Temperature Abuse
FDA (Drugs) · 2021-04-21