UROMEDICA Implantation Instrument Sheath May Damage ProACT Implants
Uromedica is recalling nonsterile implantation instrument sheaths (Lot UM00794 and UM00817) because the U-channel sheaths may damage ProACT implant devices during implantation procedures. Affected devices were distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall involving potential damage to implant devices during use. No injuries or illnesses have been reported in the source material. Since no harm has been reported and the hazard is theoretical, the severity is rated as High (3).
Plain-English summary
Uromedica Inc. is recalling the UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile. This recall affects 18 devices, specifically the U-channel sheaths included in the instrument set with lot numbers UM00794 and UM00817.
The U-channel sheaths may cause damage to ProACT implant devices when the ProACT devices are passed through the sheath during an implantation procedure. This damage could affect the proper function of the implanted device.
The affected instruments were distributed nationwide in Arizona, California, Colorado, Kansas, Maryland, Texas, and Wisconsin.
Healthcare providers and facilities that received these instruments should stop using them immediately and contact Uromedica Inc. for further information regarding the recall, including instructions for return, replacement, or disposal of the affected devices.
The recalled product
- Product
- UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
- Manufacturer
- Uromedica Inc.
- Affected units
- 18
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)
- Lot numbers UM00794 and UM00817
- UDI 00180668000106
Distribution
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