Castile Soap Towelettes Recalled Due to Bacterial Contamination
Castile soap towelettes used in Foley trays and specimen kits are recalled because they are contaminated with bacteria.
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) without reported illness, which aligns with the High severity criteria.
Plain-English summary
The U.S. Food and Drug Administration is recalling Castile soap towelettes that are included in Foley trays and midstream specimen kits. The recall is being conducted because the towelettes are contaminated with bacteria.
The affected product is the PRECSION PRM 16FR SIL FLY, Item Code PP16SD, manufactured by Covidien LLC. These towelettes are used to clean the genital area for male and female patients. A total of 95,700 units were 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 instructions on how to return or dispose of the product.
The recalled product
- Product
- Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used to clean the genital area for male and female patients
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 95,700
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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