Z-0363-2017Class II

X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product...

Name: Z-0363-2017 X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product...
Creator: C.R. Bard, Inc.
Published: 2016-10-12
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2016-10-12 / Terminated / root cause: packaging

FDA source

C.R. Bard, Inc. began a recall of 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... on 2016-10-12. FDA classified it as Class II and gives the reason as "Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0363-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-12
Posted: 2016-11-04
Terminated: 2021-09-22
Recalling firm: C.R. Bard Inc
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.
Product code: LJE Catheter, Nephrostomy
Reason for recall: Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.
Root cause tag: packaging
FDA root cause: 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 [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.
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.
Product codes and lots: Lot BMZCE039, Expiration Date 2018-12-31

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0363-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0363-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-16	2016-11-04

Product code LJE

K063632UnclassifiedX-Force N30 Nephrostomy Balloon Dilation CatheterC.R. Bard, Inc. / cleared 2007-01-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)