BioDerm Skin Wipes Recalled for Potential Bacterial Contamination
BioDerm, Inc. is voluntarily recalling specific skin wipes used in male incontinence devices due to potential bacterial contamination from a contract manufacturer.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 high-risk pathogen (bacterial contamination) without reported illness, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
BioDerm, Inc. has issued a voluntary recall of the SKIN-PREP Protective wipes component used in the BioDerm Liberty 3.0 External Male Catheter, BioDerm Liberty Pouch Clean & Dry External Male Catheter, and BioDerm Safe n' Dry devices. The recall was initiated on June 8, 2011, because the Smith and Nephew skin wipes may have been potentially contaminated with bacteria by one of their contract manufacturers.
The recalled wipes are used on intact skin to apply skin protectant for the control of male incontinence. The recall affects 26,040 units distributed nationwide in the United States, including Arizona, California, Florida, New Hampshire, New Jersey, New York, Pennsylvania, Texas, and Wisconsin, as well as in Canada and the Netherlands. Affected lot codes range from U24401 through U29801, and the product is associated with model numbers 23046, 23036, 21046, 21036, 21026, and 21006.
Consumers should check their products for the specific lot codes and model numbers listed above. If the product matches the recalled items, users should stop using the wipes and contact BioDerm, Inc. for further instructions or a replacement.
The recalled product
- 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.
- Manufacturer
- BioDerm, Inc.
- 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
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
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See all →- HighBioDerm Skin Wipes Recalled for Potential Bacterial Contamination
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- HighBioDerm Skin Wipes Recalled for Potential Bacterial Contamination
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