Recall of Bacteria-Contaminated Castile Soap Towelettes in Medical Kits
The FDA is recalling specific lots of Aplicare Castile Soap towelettes found in medical 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the bacterial contamination of a product used for patient hygiene.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Aplicare Castile Soap towelettes. 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 is due to contamination with bacteria.
The affected product is manufactured by Covidien LLC. The recall covers 16,500 units distributed nationwide in the United States and to Canada. Specific lot codes are listed in the agency's official records.
Consumers and healthcare facilities should stop using the affected towelettes and contact the manufacturer or the FDA for further instructions on disposal or replacement.
The recalled product
- Product
- Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: ¿ PP14SD ¿¿ Castile soap towelettes are used to clean the genital area for male and female patients
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 16,500
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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