FDAClass IIMarch 30, 2016

Covidien Dover P400 PREM U/M 16FR UL FOLY CSD recall: Contamination

Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD Castile soap towelettes are used to clean the genital area for male and female…

Why was Covidien Dover P400 PREM U/M 16FR UL FOLY CSD recalled?

Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Codes: 509759364X 513256864X 516050864X

Product
Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD Castile soap towelettes are used to clean the genital area for male and female…
Recalling firm
Covidien LLC
Quantity
3600
Distribution
US (nationwide) and to Canada.
Recall date
March 30, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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