Recall Z-3226-2017— C.R. Bard, Inc.

Name: FDA recall Z-3226-2017
Creator: U.S. Food and Drug Administration
Published: 2017-07-28

Class II · Terminated

Class II FDA medical device recall by C.R. Bard, Inc., initiated 2017-07-28, terminated 2020-08-25. It names one FDA 510(k) clearance: K033477. Product: Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.. Reason: Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating..

Recalling firm: C.R. Bard, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-07-28
Terminated: 2020-08-25
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

Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.

Reason for recall

Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating.

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