Recall of Bacteria-Contaminated Castile Soap Towelettes in Medical Kits
FDA is recalling 10,000 units of 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 (bacteria) in a medical device context without reported illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 10,000 units of Aplicare Castile Soap towelettes, Item Code 8000SA, manufactured by Covidien LLC. These towelettes are used to clean the genital area for male and female patients and are included in Foley Trays and Mid stream specimen kits.
The recall was initiated because the towelettes are contaminated with bacteria. The affected products are identified by Lot Codes 510450164X and 524350264X. The products were distributed nationwide in the United States and to Canada.
Consumers and healthcare facilities should stop using these specific towelettes and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- Covidien Dover KIT/STERILE PRESERVE CULT Item Code: 8000SA Castile soap towelettes are used to clean the genital area for male and female patients
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 10,000
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: 510450164X 524350264X
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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