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FDADecember 9, 2019device

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 i...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

abbott medicalabbott

UPCs

15414734014219

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 i... — Recall Details · AllClear