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
FDA Recall Z-2950-2018 · Posted None
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Recalling FirmHaemonetics Corporation
Recall StatusTerminated
Product CodeCAC
Date Initiated2018-07-13
Date Terminated2020-06-16
Product Quantity432 units
Reason for Recall
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.
Firm Action
The firm, Haemonetics, notified customers by an email titled "URGENT: MEDICAL DEVICE RECALL" on July 13, 2018 . The email described the product, problem, and actions to be taken. The customers were instructed to inspect product for defect and return units of the affected lots for replacement with non-affected units; complete the attached customer acknowledgement form via FAX TO +1-781-356-3558 OR SCAN AND E-MAIL TO: [email protected].
You can contact your local customer service representative at: North America 1.800.537.2802 or email:[email protected].
Root Cause
Process control
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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