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.
Reported: May 11, 2022 Initiated: April 1, 2022 #Z-1019-2022
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.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 300 devices
- Distribution
- Distribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS distribution to Japan, Italy, Netherlands, Switzerland, and United Kingdom
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Baxter Healthcare Corporation. Units affected: 300 devices.
Why was this product recalled? ▼
There is a potential for foreign matter.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 11, 2022. Severity: Moderate. Recall number: Z-1019-2022.
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