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
This recall has been terminated (originally issued July 13, 2018).
- Company
- Haemonetics Corporation
- Recall Initiated
- July 13, 2018
- Terminated
- June 16, 2020
- Recall Number
- Z-2950-2018
- Quantity
- 432 units
- Firm Location
- Braintree, MA
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide Distribution
Lot / Code Info
Lot # 1017049 , 1150H-00, 1017072
Root Cause
Process control
Action Taken
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: CORPORATEREGULATORY@HAEMONETICS.COM. You can contact your local customer service representative at: North America 1.800.537.2802 or email:customerservicena@haemonetics.com.