Recall of Bacteria-Contaminated Castile Soap Towelettes in Medical Kits
Covidien LLC is recalling Castile soap towelettes found in Foley trays and midstream 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 for patient hygiene, which poses a risk of harm even without reported illnesses.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for specific Castile soap towelettes manufactured by Covidien LLC. These towelettes, which are used to clean the genital area for male and female patients, were found to be contaminated with bacteria. The affected products are included in Foley trays and midstream specimen kits.
The recall covers 1,800 units of the product, identified by the item code P4P14XSD P400 and lot codes 516050264X and 522957864X. The products were distributed nationwide in the United States and to Canada.
Consumers and healthcare facilities should stop using the affected towelettes immediately. Users should check their inventory for the specific item and lot codes listed in this notice. If you have questions regarding this recall, contact the recalling firm, Covidien LLC.
The recalled product
- Product
- Covidien Dover PREM U/M 14FR SLVR FLY Item Code: P4P14XSD P400 Castile soap towelettes are used to clean the genital area for male and female patients
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 1,800
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: 516050264X 522957864X
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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