Recall Z-1743-2014 ยท NEC Bandage, Liquid, Skin Protectant
BioDerm, Inc.
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.
| Date | Jun 10, 2014 (initiated May 31, 2011) |
| Status | Terminated |
| 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. |
| Root cause | Material/Component Contamination |
| Action | Notice was sent to customers by letter dated June 8, 2011 and by phone. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.