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U.S. Department of Health and Human Services

Class 2 Device Recall XForce Nephrostomy Balloon Dilation Catheter Kit with Inflation Device

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  Class 2 Device Recall XForce Nephrostomy Balloon Dilation Catheter Kit with Inflation Device see related information
Date Initiated by Firm October 12, 2016
Create Date November 04, 2016
Recall Status1 Terminated 3 on September 22, 2021
Recall Number Z-0363-2017
Recall Event ID 75452
510(K)Number K063632  
Product Classification Catheter, nephrostomy - Product Code LJE
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.
Code Information Lot BMZCE039, Expiration Date 2018-12-31
Recalling Firm/
Manufacturer		 C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information Contact Michael Wolfe
770-784-6220
Manufacturer Reason
for Recall		 Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
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 BMD.FieldAction@crbard.com 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.
Quantity in Commerce 192 units
Distribution Worldwide distribution: US distribution to: CA, KS, MO, NY, VA, WA, and to countries of: China, Italy, Sweden and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LJE and Original Applicant = C.R. BARD, INC.
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