BioDerm Liberty 3.0 External Male Catheter Specialty recall: Contamination
BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes…
Why was BioDerm Liberty 3.0 External Male Catheter Specialty recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Codes: Range from U24401 through U29801; Model Numbers: 23046, 23036, 21046, 21036. 21026 and 21006.
- Product
- BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes…
- Recalling firm
- BioDerm, Inc.
- 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.
- Recall date
- June 18, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)