FDAClass IIJuly 15, 2020

Extra corporeal circuit with bio-active surface recall

Extra corporeal circuit with bio-active surface.

Why was Extra corporeal circuit with bio-active surface recalled?

Affected products failed a sterilization test.

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# 215729283

Product
Extra corporeal circuit with bio-active surface.
Recalling firm
Medtronic Perfusion Systems
Quantity
10 units
Distribution
Domestic Distribution only to CA and MI.
Recall date
July 15, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls