FDAClass IIMarch 30, 2016

Covidien Dover PREC PRM 16FR SILVER FLY TY recall: Contamination

Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD Castile soap towelettes are used to clean the genital area for male and female patients

Why was Covidien Dover PREC PRM 16FR SILVER FLY TY 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: 511851364X 512550364X 515357964X 518150364X 520150964X 523656964X 524356864X

Product
Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD Castile soap towelettes are used to clean the genital area for male and female patients
Recalling firm
Covidien LLC
Quantity
25080
Distribution
US (nationwide) and to Canada.
Recall date
March 30, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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