FDA Recall Terminated

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.

Recall: Z-0363-2017 · Initiated October 12, 2016

Recall

Recall Number: Z-0363-2017
Event Number: 75452
Firm: C.R. Bard, Inc.
FEI Number: 1018233
Product Code: LJE
Status: Terminated
Root Cause: Unknown/Undetermined by firm
Initiated: October 12, 2016
Terminated: September 22, 2021
Address: 8195 Industrial Blvd NE, Covington, GA, 30014-1497

Description

Reason

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

Action

The firm, Bard Medical, sent an "URGENT: MEDICAL DEVICE PRODUCT RECALL" letter dated 10/13/2016 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine product subject to recall; do not use or further distribute any affected product; complete and return the attached Recall & Effectiveness Check Form regardless of whether or not you have any of the affect product by fax to 1-770-784-6469 or email a scanned copy to [email protected] by October 24, 2016, and if you have further distributed any units of the affected lot, identify your customers and notify them at once of the product recall. If you have any questions, contact BMD Recall Coordinator at 1-800-793-8110.

Distribution

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

Quantity

192 units