—#150405

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.

FDA product code: LJE — Catheter, Nephrostomy
Device class: Class U
Medical specialty: Unknown
510(k) numbers: K063632
Affected lot / code info: Lot BMZCE039, Expiration Date 2018-12-31

Why it was recalled

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

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm: C.R. Bard, Inc.
Address: 8195 Industrial Blvd NE, Covington, Georgia 30014-1497

Distribution

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

Timeline

Recall initiated: 2016-10-12
Terminated: 2021-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150405. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.