Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
- Company
- Abbott
- Recall Initiated
- November 16, 2021
- Terminated
- June 18, 2024
- Recall Number
- Z-0420-2022
- Quantity
- 10 units
- Firm Location
- Plymouth, MN
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
Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.
Lot / Code Info
Model 407831, Lot 7748246, GTIN: 15414734008805
Root Cause
Under Investigation by firm
Action Taken
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.
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