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
Reported: September 5, 2018 Initiated: July 13, 2018 #Z-2950-2018
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.
Details
- Recalling Firm
- Haemonetics Corporation
- Units Affected
- 432 units
- Distribution
- US Nationwide Distribution
- Location
- Braintree, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Haemonetics Corporation. Units affected: 432 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 5, 2018. Severity: Moderate. Recall number: Z-2950-2018.
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