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Baxter Healthcare Corporation Recall 89897

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.

Baxter Healthcare Corporation Recall 89897 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1019-2022
Event ID89897
Event DescriptionFlo-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.
Product TypeDevices
DistributionDistribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS distribution to Japan, Italy, Netherlands, Switzerland, and United Kingdom
Quantity300 devices
Recall ReasonThere is a potential for foreign matter.
Device Classification20220511
Device Code InfoProduct Code: FT12150; Lot: SP21J21-1584173
Center Classification Date20220429
Recall Initiation Date20220401
Recalling FirmBaxter Healthcare Corporation
Initial Notification Letter
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