C.R. Bard, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0363-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 12, 2016

Date Posted: November 16, 2016

Recall Number: Z-0363-2017

Event ID: 75452

Reason for Recall:

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

Status: Terminated

Product Quantity: 192 units

Code Information:

Lot BMZCE039, Expiration Date 2018-12-31

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated