The Recall Desk
HighFDA (Devices)·Z-1214-2016·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 a high-risk pathogen (bacteria) 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

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 affects 600 units distributed nationwide in the United States and to Canada. The specific lot code for the affected product is 515359164X.

Consumers should stop using the affected towelettes and contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE Item Code: P4P18CSD Castile soap towelettes are used to clean the genital area for male and female patients
Manufacturer
Covidien LLC
Affected units
600

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: 515359164X

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 →