Z-2872-2017 Class II Terminated
FDA device recall Z-2872-2017 was initiated by C.R. Bard, Inc. on June 2, 2017 and is designated Class II. 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. The recall status is terminated (terminated July 26, 2021). Affected quantity: 2,350 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 16, 2017
- Initiation Date
- June 2, 2017
- Termination Date
- July 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,350 units
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.
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.
Code Information
Product Code 151919; Lot No. NGAS4058