FDAClass IIOctober 10, 2018

Retrograde Cardioplegia Cannula recall

Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions…

Why was Retrograde Cardioplegia Cannula recalled?

The device was built with the rigid insertion stylet instead of the flexible stylet.

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 code: 00794-030718

Product
Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions…
Recalling firm
Surge Medical Sales, LLC (DBA Surge Cardiovascular)
Quantity
35 units
Distribution
US Distribution to state of: SC.
Recall date
October 10, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls