Castile Soap Towelettes Recalled Due to Bacterial Contamination
FDA is recalling Castile soap towelettes used 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 high-risk pathogen (bacteria) without reported illness, which corresponds to a severity score of 3 (High) according to the rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling specific lots of 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 was initiated because the towelettes are contaminated with bacteria. The affected product is manufactured by Covidien LLC and is identified by the item code P4P16ULD. The specific lot codes involved in this recall are 509759364X, 513256864X, and 516050864X.
The recall covers 3,600 units that were distributed nationwide in the United States and to Canada. Consumers and healthcare facilities should check their inventory for these specific lot codes and stop using the affected towelettes if found.
The recalled product
- Product
- Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD Castile soap towelettes are used to clean the genital area for male and female patients
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 3,600
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: 509759364X 513256864X 516050864X
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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