The Recall Desk
HighFDA (Devices)·Z-1217-2016·Announced 2016-03-30

Castile Soap Towelettes Recalled Due to Bacterial Contamination

Castile soap towelettes in Foley trays and specimen kits are 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 in the rubric.

Plain-English summary

Castile soap towelettes included in Foley trays and midstream 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 involves 600 units of the product, identified by lot code 516050964X. The products were distributed nationwide in the United States and to Canada.

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 UL FOLY CSD Item Code: P4P18ULD 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: 516050964X

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 →