Abbott Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Brand
Abbott
Lot Codes / Batch Numbers
Model 407831, Lot 7748246, GTIN: 15414734008805
Products Sold
Model 407831, Lot 7748246, GTIN: 15414734008805
Abbott is recalling Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM due to As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026