FDAClass IISeptember 5, 2018

Haemonetics OrthoPAT System-Integrated Set recall

Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion system indicated for use to…

Why was Haemonetics OrthoPAT System-Integrated Set recalled?

OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the emptying of blood from the reservoirs. The inability to empty the reservoir means that the collected blood cannot be processed.

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 # 1017049 , 1150H-00, 1017072

Product
Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion system indicated for use to…
Recalling firm
Haemonetics Corporation
Quantity
432 units
Distribution
US Nationwide Distribution
Recall date
September 5, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls