Castile Soap Towelettes Recalled Due to Bacterial Contamination
FDA is recalling Castile soap towelettes 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 high-risk pathogen (bacteria) in a medical device without reported illness, meeting 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 product is the Covidien Dover P400 PREM U/M 18FR SIL FLY, Item Code P4P18SD. These towelettes are used to clean the genital area for male and female patients. The recall covers 7,200 units distributed nationwide in the United States and to Canada. The specific lot codes affected are 520857564X, 522553864X, 522958164X, 523656864X, 525153364X, and 525755664X.
Consumers and healthcare facilities should check their inventory for these specific lot codes. If the product is found, it should be removed from use and returned to the supplier or the recalling firm, Covidien LLC, in accordance with their instructions.
The recalled product
- Product
- Covidien Dover P400 PREM U/M 18FR SIL FLY Item Code: P4P18SD Castile soap towelettes are used to clean the genital area for male and female patients
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 7,200
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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