FDA-Device2016-11-16Class II
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.
C.R. Bard, Inc.
Hazard
Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.
Sold states
Worldwide distribution: US distribution to: CA, KS, MO, NY, VA, WA, and to countries of: China, Italy, Sweden and United Kingdom.
Affected count
192 units
Manufactured in
8195 Industrial Blvd NE, Covington, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0363-2017Don't want to check this manually?
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