Alaris PCA Pump, Model 8120. 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 mod
Check against the official notice below — it lists the full affected range.
CareFusion is recalling 73,611 units of the Alaris PCA Pump, Model 8120, and related Alaris Syringe Pump modules that were manufactured or serviced between May 1, 2013 and April 30, 2017. The affected devices were distributed worldwide, including throughout the United States, Canada, and numerous other countries, as well as to government and military facilities. The hazard involves the syringe plunger grippers, which may fail to automatically close around the syringe plunger press when the gripper control knob has been closed.
The recall record does not specify a remedy or recommended course of action for affected consumers.
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 10885403812002. 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.