Aplicare Castile Soap Towelettes Recalled Due to Bacterial Contamination
Aplicare Castile Soap towelettes included in Foley Trays and Mid stream specimen kits are being recalled 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 involves bacterial contamination of a medical device accessory used for patient hygiene, which poses a risk of harm, but the source text does not report specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Aplicare Castile Soap towelettes, which are included in Foley Trays and Mid stream specimen kits, are being recalled due to bacterial contamination. These towelettes are used to clean the genital area for male and female patients.
The recall involves 4,200 units of the product. The affected lot codes are 515358964X and 517457664X. The products were distributed nationwide in the United States and to Canada.
Consumers should stop using the affected towelettes and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- Covidien Dover P400 PREM U/M 16FR SIL COUDE CATH SECURE Item Code: P4P16CSD Castile soap towelettes are used to clean the genital area for male and female patients
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 4,200
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: 515358964X 517457664X
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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