Recall Z-1359-2016— C.R. Bard, Inc.

Name: FDA recall Z-1359-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-18

Class II · Terminated

Class II FDA medical device recall by C.R. Bard, Inc., initiated 2015-12-18, terminated 2016-06-29. It names one FDA 510(k) clearance: K910318. Product: BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.. Reason: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume..

Recalling firm: C.R. Bard, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-12-18
Terminated: 2016-06-29
Firm location: Covington, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K910318 — BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETERC.R. Bard, Inc.·cleared 1994-08-18

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

BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

Reason for recall

Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.

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