Z-1744-2014Class II

BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin...

Name: Z-1744-2014 BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin...
Creator: BioDerm, Inc.
Published: 2011-05-31
License: https://open.fda.gov/license/

Bioderm, Inc. / initiated 2011-05-31 / Terminated / root cause: manufacturing process

FDA source

BioDerm, Inc. began a recall of 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... on 2011-05-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1744-2014
Classification: Class II
Status: Terminated
Initiated: 2011-05-31
Posted: 2014-06-10
Terminated: 2014-06-20
Recalling firm: Bioderm, Inc.
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.
Product code: NEC Bandage, Liquid, Skin Protectant
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Notice was sent to customers by letter dated June 8, 2011 and by phone.
Quantity in commerce: 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.
Product codes and lots: Lot Codes: Range from U24401 through U29801; Model Numbers: 23046, 23036, 21046, 21036. 21026 and 21006.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1744-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1742-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1743-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10
Z-1744-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10

Product code NEC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)