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.
Reported: August 16, 2017 Initiated: June 2, 2017 #Z-2872-2017
Product Description
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.
Reason for Recall
Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.
Details
- Recalling Firm
- C.R. Bard, Inc.
- Units Affected
- 2,350 units
- Distribution
- US Nationwide in the states of CA, CO, FL, IL, IN, LA, MN, MO, NC, NJ, NY, OH, OK, PA, TX, WY, including PR.
- Location
- Covington, GA
Frequently Asked Questions
What product 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.. Recalled by C.R. Bard, Inc.. Units affected: 2,350 units.
Why was this product recalled? ▼
Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 16, 2017. Severity: Moderate. Recall number: Z-2872-2017.
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