ProACT Implantation Instrument Set recall
ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro…
Why was ProACT Implantation Instrument Set recalled?
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.
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?
Model 750041, Lot # UM00650
- Product
- ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro…
- Recalling firm
- Uromedica Inc.
- Quantity
- 11 tool sets
- Distribution
- Nationwide distribution to the following states: CA, GA, FL, MI, and VA.
- Recall date
- May 6, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)