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Recall Observatory FDA recall evidence

Device product

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

Z-2950-2018

July 13, 2018

Class II

Product summary

Firm
Haemonetics Corporation
Event
Event 80740
Status
Terminated
Classification
Class II
Quantity
432 units
Official record key
device-enforcement:Z-2950-2018

Official wording

Reason: 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.

Code information: Lot # 1017049 , 1150H-00, 1017072

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.