FDAClass IINovember 23, 2016

Cardiac Catheterization Right Heart Kit w/2-Station recall

Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifold and Transpac¿ IV Disposable Transducer, Item No. 46083-03…

Why was Cardiac Catheterization Right Heart Kit w/2-Station recalled?

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

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?

3247302

Product
Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifold and Transpac¿ IV Disposable Transducer, Item No. 46083-03…
Recalling firm
ICU Medical, Inc.
Quantity
70 units
Distribution
Nationwide Distribution
Recall date
November 23, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls