Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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 and nonsterile device.

FDA Recall Z-1743-2014 · Posted 2014-06-10

Recalling FirmBioDerm, Inc.
Recall StatusTerminated
Product CodeNEC
Date Initiated2011-05-31
Date Terminated2014-06-20
Product Quantity26,040 units.

Reason for Recall

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.

Firm Action

Notice was sent to customers by letter dated June 8, 2011 and by phone.

Root Cause

Material/Component Contamination

Distribution Pattern

Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, NH, NJ, NY, PA, TX, and WI, and the countries of Canada and Netherlands.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑