The Recall Desk
HighFDA (Devices)·Z-1222-2016·Announced 2016-03-30

Castile Soap Towelettes Recalled Due to Bacterial Contamination

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

The recall was initiated because the towelettes are contaminated with bacteria. The source text does not specify the type of bacteria or report any illnesses or injuries associated with the product.

Consumers should stop using the affected towelettes immediately. The source text does not provide specific instructions for disposal or replacement, but users should contact their healthcare provider or the manufacturer for guidance.

The recalled product

Product
Covidien Dover PRECISION PRM 16FR SIL COUDE CATH SECURE Item Code: PP16CSD Castile soap towelettes are used to clean the genital area for male and female patients
Manufacturer
Covidien LLC
Affected units
5,940

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: 512551264X 515359064X 523657564X

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 →