C.R. Bard, Inc. recalls BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients

Recalled April 20, 2016 · FDA recall Z-1357-2016 · C.R. Bard

Hazard

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

Units

1,428,000 units (total)

Sold at

Distributed US (nationwide) and the countries of Canada and Australia.

Description

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

Product

BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

Manufacturer(s)

C.R. Bard, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →