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.
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 is classified as FDA Class II and involves a potential bacterial contamination, which fits the rubric criteria for high-risk pathogens or 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 Pouch Clean & Dry External Male Catheter, BioDerm Liberty 3.0 External Male Catheter, and BioDerm Safe n' Dry. These wipes are intended for use on intact skin to apply skin protectant for the control of male incontinence.
The recall was initiated on June 8, 2011, due to a potential bacterial contamination. The affected wipes were initially manufactured by Smith & Nephew. The recall covers 26,040 units distributed nationwide in the United States, as well as in Canada and the Netherlands.
Consumers should stop using the recalled wipes immediately. The specific lot codes range from U24401 through U29801, and the affected model numbers are 23046, 23036, 21046, 21036, 21026, and 21006. Users should check their product packaging for these identifiers to determine if they are affected.
The recalled product
- Product
- 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…
- 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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