FDAClass IINovember 16, 2016

X-Force Nephrostomy Balloon Dilation Catheter Kit with recall

X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is a dual lumen…

Why was X-Force Nephrostomy Balloon Dilation Catheter Kit with recalled?

Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.

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 BMZCE039, Expiration Date 2018-12-31

Product
X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is a dual lumen…
Recalling firm
C.R. Bard, Inc.
Quantity
192 units
Distribution
Worldwide distribution: US distribution to: CA, KS, MO, NY, VA, WA, and to countries of: China, Italy, Sweden and United Kingdom.
Recall date
November 16, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls