The Recall Desk
HighFDA (Devices)·Z-1742-2014·Announced 2014-06-18

BioDerm Skin Wipes Recalled for Potential Bacterial Contamination

BioDerm, Inc. is voluntarily recalling skin-prep wipes used with external male catheters due to potential bacterial contamination.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device component with potential bacterial contamination, which poses a risk of harm, but the source text does not report any specific illnesses or injuries, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

BioDerm, Inc. has issued a voluntary recall of skin-prep protective wipes used as a component for the BioDerm Liberty 3.0 External Male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter, and BioDerm Safe n' Dry. The recall was initiated on June 8, 2011, because the wipes, which were initially manufactured by Smith & Nephew, are subject to potential bacterial contamination.

The affected wipes are used on intact skin to apply skin protectant for the control of male incontinence. The recall covers 26,040 units distributed nationwide in the United States, as well as in Canada and the Netherlands. Specific lot codes range from U24401 through U29801, and the affected model numbers are 23046, 23036, 21046, 21036, 21026, and 21006.

Consumers should stop using the affected wipes and contact BioDerm, Inc. for further instructions or a refund. The agency classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
BioDerm Liberty 3.0 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-inv
Manufacturer
BioDerm, Inc.
Category
Medical Device — External Catheter Component
Hazard
Affected units
26,040

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lot Codes: Range from U24401 through U29801
  • Model Numbers: 23046
  • 23036
  • 21046
  • 21036. 21026 and 21006.

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 3 recalled by BioDerm, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · BioDerm, Inc.

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Same hazard · bacterial contamination

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