FDAClass IIApril 18, 2018

Terumo Cardiovascular Procedure Kits containing Pall recall

Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit…

Why was Terumo Cardiovascular Procedure Kits containing Pall recalled?

Possible blood leaks through the hydrophobic portion of the Pall LG6NS LeukoGuard Leukocyte Reduction Arterial Blood Filters.

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?

662143 735568 752561 767041 774364 775404 778816 783025 785629 794402 794411 735568

Product
Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit…
Recalling firm
Terumo Cardiovascular Systems Corp
Quantity
2677
Distribution
US Distribution to the states of : AL, OH, VA, NC, GA, NY, FL
Recall date
April 18, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls