Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1019-2022 — 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.

U.S. FDA — Device Enforcement · United States · 2022-04-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1019-2022
Date of alert: 2022-04-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Baxter Healthcare Corporation
Product category: device
Product type: Devices

Reported risk: There is a potential for foreign matter.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1019-2022 — 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.

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