Castile Soap Towelettes Recalled Due to Bacterial Contamination
FDA is recalling Aplicare Castile Soap towelettes found in Foley trays and specimen kits 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 is classified as FDA Class II and involves bacterial contamination of a medical device component. Per the rubric, this falls under 'risk-of-harm products where injury has not yet been reported' or high-risk contamination without explicit hospitalization reports, warranting 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 P4P16CSDK. The recall covers 71,430 units distributed nationwide in the United States and to Canada. The affected lot codes are 511053864X, 514553364X, 515354264X, 516054064X, 516853764X, 518154764X, 518854864X, 520155564X, 520853164X, 522550264X, 522950064X, 524353064X, 525450164X, and 525752564X.
Consumers and healthcare facilities should stop using these towelettes and check their inventory for the listed lot codes. The towelettes are used to clean the genital area for male and female patients.
The recalled product
- Product
- Covidien Dover P400 UM 16FR SIL COUDE SECURE Item Code: P4P16CSDK Castile soap towelettes are used to clean the genital area for male and female patients
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 71,430
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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