Z-2950-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 5, 2018
- Initiation Date
- July 13, 2018
- Termination Date
- June 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 432 units
Product 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
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 Pattern
US Nationwide Distribution
Code Information
Lot # 1017049 , 1150H-00, 1017072