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Abbott recalls Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Recalled January 5, 2022 · FDA recall Z-0420-2022 · Abbott
Hazard
As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length. · FDA Class II
Units
10 units
Sold at
Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.
Description
As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length.
Product
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Manufacturer(s)
Abbott
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →