BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with recall: Sterility Concern
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.
Why was BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with recalled?
Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code 151919; Lot No. NGAS4058
- 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 moth other types of urinary catheters, which are intended for use for bladder management including urine drainage, collection and measurement.
- Recalling firm
- C.R. Bard, Inc.
- Quantity
- 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.
- Recall date
- August 16, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)