BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applyi
FDA device recall Z-1744-2014 · posted 2014-06-10 · Terminated
Recall details
- Recalling firm
- BioDerm, Inc.
- 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.
- Action taken
- Notice was sent to customers by letter dated June 8, 2011 and by phone.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- NEC
- Quantity affected
- 26,040 units.
- Distribution
- 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.
- Date initiated
- 2011-05-31
- Date posted
- 2014-06-10
- Date terminated
- 2014-06-20
- Location
- Largo, FL
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