Device product
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Z-0420-2022
Product summary
- Firm
- Abbott
- Event
- Event 89123
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-0420-2022
Official wording
Reason: 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.
Code information: Model 407831, Lot 7748246, GTIN: 15414734008805
Distribution pattern: Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.
Derived failure modes
-
Manufacturing or process control
manufacturing error