Recall Z-0420-2022— Abbott
Class II · Terminated
Class II FDA medical device recall by Abbott, initiated 2021-11-16, terminated 2024-06-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM. 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..
- Recalling firm
- Abbott
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-11-16
- Terminated
- 2024-06-18
- Firm location
- Plymouth, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.