FDAClass IAugust 10, 2016

Oxylog 3000 recall

Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is…

Why was Oxylog 3000 recalled?

Isolated episodes of leakage at the check valve were found

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?

Catalog Number: 5704964

Product
Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is…
Recalling firm
Draeger Medical, Inc.
Quantity
42,922 units worldwide (US distribution 1,530)
Distribution
US Nationwide Distribution including states of: AK, CA, FL, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NY,OH,OK,OR,PA,TN,TX,UT,VA,WA, and WI.
Recall date
August 10, 2016
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls