Abbott Medical: 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 angiograph

Is my product affected?

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

• UPC 15414734014219

Check against the official notice below — it lists the full affected range.

What happened

Abbott Medical has recalled 380 Fast-Cath Hemostasis Introducer devices across three lots due to a manufacturing error. The recalled devices contained 8F sized dilators and sheaths instead of the correct 8.5F size. The affected lots are: Batch 6917183 (expiration 220228), Batch 6950628 (expiration 220331), and Batch 7099144 (expiration 220630). These devices were distributed worldwide, including throughout the United States in Massachusetts, Virginia, New Hampshire, Florida, Connecticut, Utah, Ohio, Wisconsin, New York, Iowa, Michigan, Mississippi, and Pennsylvania, as well as in Canada and the Czech Republic.

The recall notice does not specify what actions affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices. Distribution: Worldwide distribution - US Nationwide distribution in the states of MA, VA, NH, FL, CT, UT, OH, WI, NY, IA, MI, MS, PA, and countries of Canada, Czech Republic Quantity: 380 devices Lot/code info: Batch 6917183; UDI (01)15414734014219(17)220228(10)6917183 Batch 6950628; UDI (01)15414734014219(17)220331(10)6950628 Batch 7099144; UDI (01)15414734014219(17)220630(10)7099144

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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