Recall Z-0363-2017— C.R. Bard, Inc.

Name: FDA recall Z-0363-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-12

Class II · Terminated

Class II FDA medical device recall by C.R. Bard, Inc., initiated 2016-10-12, terminated 2021-09-22. It names one FDA 510(k) clearance: K063632. 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.. Reason: Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr..

Recalling firm: C.R. Bard, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-10-12
Terminated: 2021-09-22
Firm location: Covington, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K063632 — X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETERC.R. Bard, Inc.·cleared 2007-01-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.