Z-1019-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 11, 2022
- Initiation Date
- April 1, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 300 devices
Product Description
Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.
Reason for Recall
There is a potential for foreign matter.
Distribution Pattern
Distribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS distribution to Japan, Italy, Netherlands, Switzerland, and United Kingdom
Code Information
Product Code: FT12150; Lot: SP21J21-1584173