Castile Soap Towelettes in Medical Kits Recalled for Bacterial Contamination
The FDA is recalling Castile soap towelettes included in Foley trays and 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 risk-of-harm product (bacterial contamination in a medical device) where the source text does not explicitly report injuries or illnesses, fitting the criteria 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 products are manufactured by Covidien LLC. The specific item code is PP16XSD, and the product is described as Castile soap towelettes used to clean the genital area for male and female patients. The recall covers 25,080 units distributed nationwide in the United States and to Canada.
Consumers and healthcare facilities should stop using the affected towelettes and return them to the supplier or the manufacturer for a refund or replacement. The specific lot codes associated with this recall are 511851364X, 512550364X, 515357964X, 518150364X, 520150964X, 523656964X, and 524356864X.
The recalled product
- Product
- Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD Castile soap towelettes are used to clean the genital area for male and female patients
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 25,080
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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