FDAClass IIMarch 30, 2016

Covidien Dover P400 PREM U/M 16FR SIL FLY recall: Contamination

Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap towelettes are used to clean the genital area for male and female patients

Why was Covidien Dover P400 PREM U/M 16FR SIL FLY 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: 511053864X 514553364X 515354264X 516054064X 516853764X 518154764X 518854864X 520155564X 520853164X 522550264X 522950064X 524353064X 525450164X 525752564X

Product
Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap towelettes are used to clean the genital area for male and female patients
Recalling firm
Covidien LLC
Quantity
83400
Distribution
US (nationwide) and to Canada.
Recall date
March 30, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls