Summary
The FDA issued a Class II for Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM by Abbott. 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..
Details
Source
Device Recall
External ID
Z-0420-2022
Action Date
2022-01-05
Status
Terminated
Category
device
Product Description
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Lot/Code Info: Model 407831, Lot 7748246, GTIN: 15414734008805
Quantity Affected: 10 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-16
Company
Plymouth, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 90 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Abbott has 21 FDA actions in our database, including 15 recalls and 6 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott have FDA actions?
Abbott has 21 FDA actions in our database, including 15 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0420-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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