Haemonetics Corporation recalls Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion sy…

Recall date

July 13, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2950-2018

FDA classification

Class II

Brand / firm

Haemonetics Corporation

Sold / distributed

US Nationwide Distribution

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures