Castile Soap Towelettes in Medical Kits Recalled for Bacterial Contamination
FDA is recalling Castile soap towelettes 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 risk-of-harm product (bacterial contamination) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Castile soap towelettes that are included in Foley trays and midstream specimen kits. The recall is being conducted by the manufacturer, Covidien LLC.
The recall was initiated because the towelettes are contaminated with bacteria. These products are used to clean the genital area for male and female patients. The affected units were distributed nationwide in the United States and to Canada.
Consumers and healthcare facilities should stop using the affected towelettes immediately. The specific lot codes for the recalled products are 511059764X, 516853664X, 521750064X, and 525350464X. The total quantity of units involved in this recall is 13,060.
The recalled product
- Product
- Covidien Dover PREM 16FR UL LTX FOLEY TRY CSD Item Code: PP16ULD Castile soap towelettes are used to clean the genital area for male and female patients
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 13,060
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: 511059764X 516853664X 521750064X 525350464X
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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