Recall Z-2872-2017— C.R. Bard, Inc.
Class II · Terminated
Class II FDA medical device recall by C.R. Bard, Inc., initiated 2017-06-02, terminated 2021-07-26. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier..
- Recalling firm
- C.R. Bard, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-02
- Terminated
- 2021-07-26
- Firm location
- Covington, GA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.