C.R. Bard, Inc. recalls X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081…

Recall date

October 12, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0363-2017

FDA classification

Class II

Brand / firm

C.R. Bard, Inc.

Sold / distributed

Worldwide distribution: US distribution to: CA, KS, MO, NY, VA, WA, and to countries of: China, Italy, Sweden and United Kingdom.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath the balloon. It is recommended for use in the dilation of the nephrostomy tact and for placement of the working sheath.