FDAClass IIMarch 30, 2016

Covidien Dover PRECSION PRM 16FR SIL FLY recall: Contamination

Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used to clean the genital area for male and female patients

Why was Covidien Dover PRECSION PRM 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: 511059464X 511851964X 513256664X 514650264X 515358464X 516050764X 516858564X 517457464X 520151064X 521058864X 522551264X 522958464X 523657064X 524357064X 525755764X 525755864X

Product
Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used to clean the genital area for male and female patients
Recalling firm
Covidien LLC
Quantity
95700
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