FDA-Device2022-01-05Class II
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
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.
Sold states
Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.
Affected count
10 units
Manufactured in
5050 Nathan Ln N, Plymouth, MN, United States
Products
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0420-2022Don't want to check this manually?
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