Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Check against the official notice below — it lists the full affected range.
Abbott has recalled one lot of Ultimum Hemostasis Introducer 5F devices due to a manufacturing error. Ten units of Model 407831, Lot 7748246 were produced at 12 cm in length instead of the intended 5 cm in length, and also have an incorrect hub. The affected devices were distributed worldwide, including US Nationwide distribution in Missouri and in Australia.
The source document does not specify a remedy or instructions for what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 10 units Lot/code info: Model 407831, Lot 7748246, GTIN: 15414734008805
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.