The Recall Desk
HighFDA (Devices)·Z-1228-2016·Announced 2016-03-30

Castile Soap Towelettes Recalled for Bacterial Contamination

FDA is recalling Aplicare Castile Soap towelettes in Foley trays and specimen kits due to bacterial contamination.

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 is classified as FDA Class II and involves bacterial contamination of a medical device used for patient hygiene, which presents a risk of harm without reported fatalities or specific hospitalization data in the source text.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Aplicare Castile Soap towelettes that are included in Foley Trays and Mid stream specimen kits. The recall is due to the product being contaminated with bacteria.

The affected products are manufactured by Covidien LLC. The specific items are the PPREM 18FR UL LTX FOLEY TRY CSD (Item Code: P18ULD). The recall covers 1,980 units distributed nationwide in the United States and to Canada. The affected lot codes are 509054664X, 512550964X, and 525154064X.

These towelettes are used to clean the genital area for male and female patients. The FDA has classified this as a Class II recall. Consumers and healthcare facilities should stop using the affected products and contact the manufacturer or their supplier for further instructions.

The recalled product

Product
Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD Item Code: P18ULD Castile soap towelettes are used to clean the genital area for male and female patients
Manufacturer
Covidien LLC
Affected units
1,980

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: 509054664X 512550964X 525154064X

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 →