FDAClass IIApril 23, 2014

Terumo Cardiovascular Procedure Kit- X-Coated Pump and recall

Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431

Why was Terumo Cardiovascular Procedure Kit- X-Coated Pump and recalled?

Incorrect customer notification label applied to the Tyvek lid of this specific lot of Terumo¿ Cardiovascular Procedure Kits

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 Number: RA-27

Product
Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
Recalling firm
Terumo Cardiovascular Systems Corp
Quantity
37 units
Distribution
CA
Recall date
April 23, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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