UROMEDICA Implantation Instrument Set recall
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Why was UROMEDICA Implantation Instrument Set recalled?
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers UM00794 and UM00817, UDI 00180668000106
- Product
- UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
- Recalling firm
- Uromedica Inc.
- Quantity
- 18 devices
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI.
- Recall date
- January 12, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)