—#157782

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.

FDA product code: KNX — Collector, Urine, (And Accessories) For Indwelling Catheter
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Product Code 151919; Lot No. NGAS4058

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.

Root cause (FDA determination)

Process control

Action the firm took

Bard Medical a Medical Device letter dated June 2, 2017 to affected customers via FedEx. The letter identified the affected product, problem and actions to be taken. The notification requests that consignees examine inventory and identify any product on hand. The firm indicates that product return is not required, but customers are encouraged to call 1-800-526-4455 if product doesn't meet their needs or if they have any questions regarding the recall. If product was further distributed, the firm requests that the provided recall notification be forwarded to the respective organization.

Recalling firm

Firm: C.R. Bard, Inc.
Address: 8195 Industrial Blvd NE, Covington, Georgia 30014-1497

Distribution

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

Timeline

Recall initiated: 2017-06-02
Terminated: 2021-07-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157782. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.