Agency classClass IIOur severity:Severe FDA (Devices)·Z-1219-2016·Announced 2016-03-30

Castile Soap Towelettes Recalled Due to Bacterial Contamination

Covidien LLC is recalling Castile soap towelettes found 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which involves a risk of temporary or medically reversible health consequences. The presence of bacterial contamination in a product used for genital cleaning represents a significant health hazard, fitting the criteria for a Severe rating.

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, used to clean the genital area for male and female patients, were found to be contaminated with bacteria.

The recalled products are included in Foley Trays and Mid stream specimen kits. The recall affects 4,500 units distributed nationwide in the United States and to Canada. The specific lot codes for the affected items are 516853264X, 517457164X, and 525153464X.

Consumers and healthcare facilities should stop using these towelettes immediately. Users should check their inventory for the listed lot codes and contact the manufacturer or their supplier for instructions on returning the product or obtaining a replacement.

The recalled product

Product: Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: ¿¿¿ P4P18XSD Castile soap towelettes are used to clean the genital area for male and female patients
Manufacturer: Covidien LLC
Category: Medical Device — Hygiene Towelettes
Hazard: bacterial-contamination
Affected units: 4,500

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: 516853264X 517457164X 525153464X

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.

See all 34 products in this recall →

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Same hazard · bacterial contamination