Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
FDA Recall Z-0420-2022 · Posted None
Recalling FirmAbbott
Recall StatusTerminated
Product CodeDYB
Date Initiated2021-11-16
Date Terminated2024-06-18
Product Quantity10 units
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.
Firm Action
The firm initiated the recall by telephone on 16 NOV 2021 followed by a letter emailed on 18 NOV 2021. The letter explained the problem and requested the return of the affected devices.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.