Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe pumps on the market. The
Check against the official notice below — it lists the full affected range.
CareFusion issued a recall for 73,611 Alaris Syringe Pump Model 8110 devices and Alaris PCA modules manufactured or serviced between May 1, 2013 and April 30, 2017. The recalled devices have a defect where the syringe plunger grippers may fail to automatically close around the syringe plunger press even after the gripper control knob has been closed. The affected devices were distributed worldwide, including throughout the United States and to government and military facilities, as well as internationally to Canada, the United Arab Emirates, Bahrain, Switzerland, the United Kingdom, Kuwait, Mexico, Malaysia, the Netherlands, New Zealand, Qatar, Saudi Arabia, Taiwan, and South Africa.
The affected products can be identified by UDI 10885403810015. The recall notice does not specify a remedy or recommended action for consumers in possession of these devices.
Written by software from the official notice below. Not reviewed by a lawyer.
The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.
Reason for recall: The syringe plunger grippers may fail to automatically close around the syringe plunger press when the gripper control knob has been closed. Distribution: Worldwide Distribution - USA (nationwide) Distribution. There was also government and military distribution. Foreign distribution was made to Canada, United Arab Emirates, Bahrain, Canada, Switzerland, United Kingdom, Kuwait, Mexico, Malaysia, The Netherlands, New Zealand, Qatar, Saudi Arabia, Taiwan, and South Africa. Quantity: 73,611 Lot/code info: UDI 10885403810015. Product involved are those devices manufactured and/or serviced between 5/1/2013 through 4/30/2017.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.