Z-2872-2017Class II

BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz...

Name: Z-2872-2017 BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz...
Creator: C.R. Bard, Inc.
Published: 2017-06-02
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2017-06-02 / Terminated / root cause: manufacturing process

FDA source

C.R. Bard, Inc. began a recall of 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... on 2017-06-02. FDA classified it as Class II and gives the reason as "Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2872-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-02
Posted: 2017-08-10
Terminated: 2021-07-26
Recalling firm: C.R. Bard Inc
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.
Product code: KNX Collector, Urine, (And Accessories) For Indwelling Catheter
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 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.
Product codes and lots: Product Code 151919; Lot No. NGAS4058

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2872-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2872-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-16	2017-08-10

Product code KNX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)