Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anast
Summary
The FDA issued a Class II for Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular proc by Baxter Healthcare Corporation. Reason: There is a potential for foreign matter..
Details
Source
Device Recall
External ID
Z-1019-2022
Action Date
2022-05-11
Status
Completed
Category
device
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.
Lot/Code Info: Product Code: FT12150; Lot: SP21J21-1584173
Quantity Affected: 300 devices
Reason for Recall
There is a potential for foreign matter.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-01
Company
Deerfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 121 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1019-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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