Castile Soap Towelettes Recalled Due to Bacterial Contamination
FDA is recalling Aplicare Castile Soap towelettes found in Foley trays and specimen kits due to bacterial contamination.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 the hazard involves bacterial contamination of a medical device used on patients, which poses a risk of harm even without reported illnesses.
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 the Covidien Dover P400 PREM U/M 16FR SLVR FLY, Item Code P4P16XSD. These towelettes are used to clean the genital area for male and female patients. The recall covers 31,200 units distributed nationwide in the United States and to Canada. Specific lot codes involved in the recall include 513256264X, 515358164X, 517457064X, 520550064X, 520857464X, 521058564X, 522958064X, and 525153264X.
Healthcare facilities and consumers should stop using the affected towelettes and contact the recalling firm, Covidien LLC, for further instructions or a refund.
The recalled product
- Product
- Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes are used to clean the genital area for male and female patients
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 31,200
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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