Recall Z-1744-2014— 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 Safe n' Dry 21006 (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 (Smith and Nephew skin wipes) used in the BioDerm Liberty 3.0 External Male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. Potential bacterial contamination of Smith and Nephew skin wipes by one of their contract manufacturers..
- 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 Safe n' Dry 21006 (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 (Smith and Nephew skin wipes) used in the BioDerm Liberty 3.0 External Male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter and BioDerm Safe n' Dry. Potential bacterial contamination of Smith and Nephew skin wipes by one of their contract manufacturers.
Data sourced from openFDA. This site is unofficial and independent of the FDA.