Recall of Bacteria-Contaminated Castile Soap Towelettes in Medical Kits
The FDA is recalling Aplicare Castile Soap towelettes included in Foley trays and midstream specimen kits due to 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 high-risk pathogen (bacteria) in a medical device context without reported illness, which aligns with the rubric for a High severity score.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Aplicare Castile Soap towelettes that are included in Foley Trays and Mid stream specimen kits. The recall is being conducted because the towelettes are contaminated with bacteria.
The affected product is the Covidien Dover P400 PREM U/M 16FR SIL FLY (Item Code: P4P16SD). These towelettes are used to clean the genital area for male and female patients. The recall covers 83,400 units distributed nationwide in the United States and to Canada.
Consumers and healthcare facilities should stop using the affected towelettes and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap towelettes are used to clean the genital area for male and female patients
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 83,400
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 recalled by Covidien LLC 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.
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