Castile Soap Towelettes Recalled Due to Bacterial Contamination
The FDA is recalling Aplicare Castile Soap towelettes found 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 used on patients, but the source text does not report any illnesses or injuries, 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 products are manufactured by Covidien LLC. The specific items are identified by the product name "Covidien Dover P400 PREM U/M 16FR TMP SNS CSD" and Item Code P4P16TSD. The lot codes for the recalled units are 520858164X and 525756164X. A total of 7,200 units were distributed nationwide in the United States and to Canada.
These towelettes are used to clean the genital area for male and female patients. Consumers and healthcare facilities should check their inventory for these specific lot codes and stop using the affected products immediately.
The recalled product
- Product
- Covidien Dover P400 PREM U/M 16FR TMP SNS CSD Item Code: P4P16TSD 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: 520858164X 525756164X
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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