Device 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.
Z-2872-2017
Product summary
- Firm
- C.R. Bard, Inc.
- Event
- Event 77733
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,350 units
- Official record key
device-enforcement:Z-2872-2017
Official wording
Reason: Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.
Code information: Product Code 151919; Lot No. NGAS4058
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.
Derived failure modes
-
Sterility assurance
breach of the product's sterile barrier