Z-1019-2022 Class II Terminated
FDA device recall Z-1019-2022 was initiated by Baxter Healthcare Corporation on Apr 1, 2022 and is designated Class II. Reason for recall: There is a potential for foreign matter. The recall status is terminated (terminated Jul 10, 2026). Affected quantity: 300 devices.
Recall Details
- Product Type
- Devices
- Report Date
- May 11, 2022
- Initiation Date
- Apr 1, 2022
- Termination Date
- Jul 10, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 300 devices
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.
Distribution Pattern
Distribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS distribution to Japan, Italy, Netherlands, Switzerland, and United Kingdom
Code Information
Product Code: FT12150; Lot: SP21J21-1584173
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1019-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026