FDA-Device2018-09-05Class II
Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures
Haemonetics Corporation
Hazard
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.
Sold states
US Nationwide Distribution
Affected count
348 units
Manufactured in
400 Wood Rd, N/A, Braintree, MA, United States
Products
Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code: OPT-R-1000 The OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2951-2018Don't want to check this manually?
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