Recall Z-1743-2014— BioDerm, Inc.
Class II · Terminated
Class II FDA medical device recall by BioDerm, Inc., initiated 2011-05-31, terminated 2014-06-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- BioDerm, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-05-31
- Terminated
- 2014-06-20
- Firm location
- Largo, FL, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.