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

Recall Z-2079-2021 — Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

U.S. FDA — Device Enforcement · United States · 2021-06-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2079-2021
Date of alert: 2021-06-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cordis Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 17919780

Reported risk: The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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-2079-2021 — Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

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