Castile Soap Towelettes Recalled Due to Bacterial Contamination
Covidien LLC is recalling Castile soap towelettes used in Foley trays and specimen kits because they are contaminated with bacteria.
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 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 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Covidien LLC is recalling 3,280 units of Castile soap towelettes (Item Code: PP18XSD) 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 identified by Lot Codes 512550464X and 525153664X. These items were distributed nationwide in the United States and to Canada. The towelettes are used to clean the genital area for male and female patients.
Consumers and healthcare facilities should stop using the affected towelettes and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Covidien Dover PREC PRM 18FR SILVER FLY TY Item Code: PP18XSD Castile soap towelettes are used to clean the genital area for male and female patients
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 3,280
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: 512550464X 525153664X
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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