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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
Recalled November 16, 2016 · FDA recall Z-0363-2017 · C.R. Bard
Hazard
Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr. · FDA Class II
Units
192 units
Sold at
Worldwide distribution: US distribution to: CA, KS, MO, NY, VA, WA, and to countries of: China, Italy, Sweden and United Kingdom.
Description
Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.
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 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.
Manufacturer(s)
C.R. Bard, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →