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U.S. Department of Health and Human Services

Class 2 Device Recall Ultimum HEMOSTASIS INTRODUCER

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  Class 2 Device Recall Ultimum HEMOSTASIS INTRODUCER see related information
Date Initiated by Firm November 16, 2021
Create Date December 27, 2021
Recall Status1 Open3, Classified
Recall Number Z-0420-2022
Recall Event ID 89123
Product Classification Introducer, catheter - Product Code DYB
Product Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Code Information Model 407831, Lot 7748246, GTIN: 15414734008805
Recalling Firm/
5050 Nathan Ln N
Plymouth MN 55442-3209
For Additional Information Contact Alicia Swanson
Manufacturer 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.
FDA Determined
Cause 2
Under Investigation by firm
Action 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.
Quantity in Commerce 10 units
Distribution Worldwide distribution - US Nationwide distribution in the state of Missouri and the country of Australia.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.