Recall Z-2950-2018 ยท CAC Apparatus, Autotransfusion
Haemonetics Corporation
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
| Date | Jul 13, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| 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: CORPORATEREGULATORY@HAEMONETICS.COM. You can contact your local customer service representative at: North America 1.800.537.2802 or email:customerservicena@haemonetics.com. |
| Quantity | 432 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992723 | ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM Transfusion Technologies Corp., Oct 18, 1999 |