Recall of Bacteria-Contaminated Castile Soap Towelettes in Medical Kits
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 medical device contaminated with bacteria, which poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting 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 and are used to clean the genital area for male and female patients. The recall covers 20,400 units distributed nationwide in the United States and to Canada. Specific lot codes for the recalled items are 513256364X, 514555864X, 516050164X, 516852964X, and 517456764X.
Healthcare facilities and consumers should stop using these towelettes immediately. Users should check their inventory for the specific item codes and lot numbers listed above. If you have questions about this recall, contact the recalling firm, Covidien LLC.
The recalled product
- Product
- Covidien Dover PREM U/M 14FR SIL FLY Item Code: P4P14SD P400 Castile soap towelettes are used to clean the genital area for male and female patients
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 20,400
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: 513256364X 514555864X 516050164X 516852964X 517456764X
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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