Z-0420-2022 Class II Terminated
FDA device recall Z-0420-2022 was initiated by Abbott on November 16, 2021 and is designated Class II. 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 in… The recall status is terminated (terminated June 18, 2024). Affected quantity: 10 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 5, 2022
- Initiation Date
- November 16, 2021
- Termination Date
- June 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
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 Pattern
Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.
Code Information
Model 407831, Lot 7748246, GTIN: 15414734008805