Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 — recall Z-2872-2017

U.S. FDA — Device Enforcement · United States · 2017-06-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2872-2017
Date of alert: 2017-06-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: C.R. Bard, Inc.
Product category: device
Product type: Devices

Reported risk: Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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