Medical device manufacturer, Abbott, issued a medical device safety alert concerning its Ultimum Hemostasis Introducer [Model 407831; Lot 7748246; GTIN: 15414734008805]
The manufacturer is voluntarily recalling one lot of the Ultimum Hemostasis Introducer (Model 407831; Lot 7748246). According to the manufacturer, because of a manufacturing error, one 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. The result is an assembly in which the dilator does not protrude out the distal end of the sheath. If an affected device is used, the risk of injury is low and limited to risks associated with delay of procedure while the device is replaced.
The manufacturer is instructing affected users the following:
According to the local supplier, the affected devices are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 Nov 2021