Castile Soap Towelettes Recalled Due to Bacterial Contamination
FDA is recalling Aplicare Castile Soap towelettes found in medical 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 (bacterial contamination) without reported illness, which aligns with the 'High' severity criteria in the rubric.
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 manufactured by Covidien LLC. The specific item is the P400 PREM UM 16FR SILV TMP CSD (Item Code: P4P16XTSD). 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 affected lot codes are 515358664X, 518150564X, and 522551064X.
Consumers and healthcare facilities should stop using the affected towelettes and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- Covidien Dover P400 PREM UM 16FR SILV TMP CSD Item Code: P4P16XTSD Castile soap towelettes are used to clean the genital area for male and female patients
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 7,200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Codes: 515358664X 518150564X 522551064X
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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