FDAClass IINovember 12, 2014

Terumo Cardioplegia Delivery Set recall

Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic…

Why was Terumo Cardioplegia Delivery Set recalled?

Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line

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 Numbers: MN08, MNI5, MM11, MM18, MM25. Manufacturing dates October 1I, 2010 through Novemberl5, 20 I 0.

Product
Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic…
Recalling firm
Terumo Cardiovascular Systems Corp
Quantity
777 units
Distribution
Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
Recall date
November 12, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls