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

Recall Z-1743-2014 — BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive

U.S. FDA — Device Enforcement · United States · 2011-05-31 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1743-2014
Date of alert: 2011-05-31
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: BioDerm, Inc.
Product category: device
Product type: Devices

Reported risk: On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm Liberty 3.0 External male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. This component (wipes) were initially manufacturer by Smith & Nephew and recalled due to a potential bacterial contamination.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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