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

Recall Z-0783-2020 — Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303

U.S. FDA — Device Enforcement · United States · 2019-12-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0783-2020
Date of alert
2019-12-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Abbott Medical
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
15414734203903
Reported risk: Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
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.

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