The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2872-2017·Announced 2017-08-16

C.R. Bard Recalls Leg Bags Due to Potential Sterile Barrier Breach

C.R. Bard is recalling 2,350 units of Bard Dispoz-A-Bag leg bags due to a reported cut in the side that may compromise the sterile barrier.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a potential breach of the sterile barrier for a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

C.R. Bard, Inc. is recalling 2,350 units of Bard Dispoz-A-Bag Leg Bags with Flip-Flo Valve, Drain Extension, Extension Tube, and Latex Straps. The affected product is identified by Product Code 151919 and Lot No. NGAS4058. These vinyl leg bags are intended for use with male external catheters, Foley catheters, or other urinary catheters for bladder management, including urine drainage, collection, and measurement.

The recall was initiated following a customer complaint regarding a cut in the side of the leg bag. This defect indicates a potential breach of the product's sterile barrier. The agency has classified this recall as Class II.

The affected units were distributed nationwide in the states of California, Colorado, Florida, Illinois, Indiana, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, and Wyoming, as well as Puerto Rico. Consumers and healthcare providers should stop using the affected product and contact C.R. Bard, Inc. for instructions on return or replacement.

The recalled product

Product
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…
Manufacturer
C.R. Bard, Inc.
Category
Medical Device — Urinary Catheter Accessories
Hazard
Affected units
2,350

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Product Code 151919
  • Lot No. NGAS4058

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

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