Baxter Flo-Thru Intraluminal Shunt Recall for Potential Foreign Matter
Baxter Healthcare is recalling Flo-Thru Intraluminal Shunts due to potential foreign matter contamination. The recall involves 300 devices distributed in the U.S. and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a high-risk vascular surgical device with no reported patient injuries or adverse events. It meets the rubric criterion of 'risk-of-harm products where injury has not yet been reported,' as foreign matter contamination in intraluminal shunts could potentially cause serious vascular complications.
Plain-English summary
Baxter Healthcare Corporation is recalling the Flo-Thru Intraluminal Shunt, a medical device used in coronary artery and peripheral vascular surgical procedures. These shunts are designed to provide a blood-free operative field during suturing by shunting blood at the anastomosis while allowing blood to flow distal to the operative site.
The recall was initiated due to a potential for foreign matter contamination in the recalled devices. Lot SP21J21-1584173 is affected.
Approximately 300 devices have been distributed in the United States (AL, CA, KY, NY, OR, PA, and TX) and internationally (Japan, Italy, Netherlands, Switzerland, and United Kingdom). No adverse events or patient injuries have been reported in association with this recall.
The recalled product
- Product
- 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.
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 300
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product Code: FT12150
- Lot: SP21J21-1584173
Distribution
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