NephroMax high Pressure nephrostomy Balloon Catheter recall
NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the…
Why was NephroMax high Pressure nephrostomy Balloon Catheter recalled?
Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
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 Number: 15982017, 15963887, 16034014
- Product
- NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 15 units
- Distribution
- Worldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.
- Recall date
- July 17, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)