C.R. Bard, Inc. recalls BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as…

Recall date

June 2, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2872-2017

FDA classification

Class II

Brand / firm

C.R. Bard, Inc.

Sold / distributed

US Nationwide in the states of CA, CO, FL, IL, IN, LA, MN, MO, NC, NJ, NY, OH, OK, PA, TX, WY, including PR.

Why it was recalled

Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in thermoformed trays. There are 50 units per case. Product Usage: Vinyl leg bag to be used with male external catheters, Foley catheters, or moth other types of urinary catheters, which are intended for use for bladder management including urine drainage, collection and measurement.