The Recall Desk
HighFDA (Devices)·Z-1215-2016·Announced 2016-03-30

Castile Soap Towelettes Recalled Due to Bacterial Contamination

The FDA is recalling Castile soap towelettes included in Foley trays and specimen kits 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) in a medical device context 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

The U.S. Food and Drug Administration (FDA) is recalling specific Castile soap towelettes manufactured by Covidien LLC. These towelettes, which are used to clean the genital area for male and female patients, are included in Foley trays and midstream specimen kits.

The recall was initiated because the towelettes are contaminated with bacteria. The affected product is identified by the item code P4P18CSDK and specific lot codes: 511752564X, 516054164X, 520853264X, and 525450264X. A total of 11,400 units were distributed nationwide in the United States and to Canada.

Consumers and healthcare facilities should check their inventory for these specific lot codes and discontinue use of the affected towelettes. The source text does not provide specific instructions for disposal or return, but users should follow standard medical waste protocols or contact the manufacturer for guidance.

The recalled product

Product
Covidien Dover P400 UM 18FR SIL COUDE SECURE Item Code: P4P18CSDK Castile soap towelettes are used to clean the genital area for male and female patients
Manufacturer
Covidien LLC
Affected units
11,400

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: 511752564X 516054164X 520853264X 525450264X

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 →