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
Recall
- Recall Number
- Z-2950-2018
- Event Number
- 80740
- Firm
- Haemonetics Corporation
- FEI Number
- 1219343
- Product Code
- CAC
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- July 13, 2018
- Terminated
- June 16, 2020
- Address
- 400 Wood Rd, Braintree, MA, 02184-2412
Description
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
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.
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].
US Nationwide Distribution
432 units