Flo-Thru Intraluminal Shunt. Used in coronary artery or recall: Foreign Material
Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary…
Why was Flo-Thru Intraluminal Shunt. Used in coronary artery or recalled?
There is a potential for foreign matter.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code: FT12150; Lot: SP21J21-1584173
- Product
- Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary…
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 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
- Recall date
- May 11, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)