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

Recall Z-0789-2020 — Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is e

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-0789-2020
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): 15414734014219

Reported risk: Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F 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.

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.

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