UltraxxTM Nephrostomy Balloon Set The Ultraxx" recall: Labeling Error
UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation…
Why was UltraxxTM Nephrostomy Balloon Set The Ultraxx" recalled?
Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and the Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set because of a labeling mix-up. Cook Medical has received reports of packages labeled as Ultraxx" Nephrostomy Balloon Set actually containing the Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set and vice versa.
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?
Catalog # UNBS-1 0-15-CS GPN# G30357 Lot# 5082013 Exp: 06/01/2017
- Product
- UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation…
- Recalling firm
- Cook Inc.
- Quantity
- 20
- Distribution
- Worldwide Distribution - US including GA, ID, LA, OR, SC, TX and Internationally to CHINA.
- Recall date
- March 30, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)