Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Reported: January 5, 2022 Initiated: November 16, 2021 #Z-0420-2022
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.
Details
- Recalling Firm
- Abbott
- Units Affected
- 10 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.
- Location
- Plymouth, MN
Frequently Asked Questions
What product was recalled? ▼
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM. Recalled by Abbott. Units affected: 10 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 5, 2022. Severity: Moderate. Recall number: Z-0420-2022.
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