FDA recall Z-0420-2022

Product

Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM

Reason for recall

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.

Distribution

Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.

Key facts

Status

Terminated

Initiation date

2021-11-16

Report date

2022-01-05

Termination date

2024-06-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plymouth, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0420-2022