Castile Soap Towelettes Recalled Due to Bacterial Contamination
FDA is recalling Castile soap towelettes in Foley trays and 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 involves a high-risk pathogen (bacteria) in a medical device without reported illness, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Castile soap towelettes manufactured by Covidien LLC. These towelettes are included in Foley trays and midstream specimen kits and are used to clean the genital area for male and female patients.
The recall was initiated because the towelettes are contaminated with bacteria. The affected product is identified by the item code PP14XSD and lot code 518150464X. A total of 1,320 units were distributed nationwide in the United States and to Canada.
Consumers and healthcare facilities should stop using the affected towelettes immediately. The FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Covidien Dover PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD ¿ ¿¿ Castile soap towelettes are used to clean the genital area for male and female patients
- Manufacturer
- Covidien LLC
- Hazard
- Affected units
- 1,320
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: 518150464X
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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