The Recall Desk
HighFDA (Devices)·Z-1226-2016·Announced 2016-03-30

Castile Soap Towelettes Recalled Due to Bacterial Contamination

Aplicare Castile Soap towelettes included in Foley Trays and Mid stream specimen kits are being recalled because they are contaminated with bacteria.

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 bacterial contamination of a medical device component, which poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Aplicare Castile Soap towelettes, which are included in Foley Trays and Mid stream specimen kits, are being recalled due to bacterial contamination. These towelettes are used to clean the genital area for male and female patients.

The recall is being conducted by Covidien LLC. The source text does not specify the number of units affected, the specific distribution dates, or the exact geographic scope beyond the general context of the recall notice.

Consumers who have these products should stop using them and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD Castile soap towelettes are used to clean the genital area for male and female patients
Manufacturer
Covidien LLC
Affected units
1,950

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: 512551364X 516051164X 521750164X

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 →