Recall Z-0198-2016— C.R. Bard, Inc.

Name: FDA recall Z-0198-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-02

Class III · Terminated

Class III FDA medical device recall by C.R. Bard, Inc., initiated 2015-10-02, terminated 2016-08-01. It names one FDA 510(k) clearance: K033477. Product: Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units. Reason: Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French..

Recalling firm: C.R. Bard, Inc.
Classification: Class III
Status: Terminated
Initiated: 2015-10-02
Terminated: 2016-08-01
Firm location: Covington, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K033477 — HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KITRochester Medical Corp.·cleared 2004-06-10

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

Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units

Reason for recall

Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French.

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