Class 2 Device Recall Alaris Syringe

• Date Initiated by Firm: November 17, 2017
• Create Date: January 08, 2018
• Recall Status: Terminated on May 04, 2020
• Recall Number: Z-0322-2018
• Recall Event ID: 78588
• 510(K)Number: K023264
• Product Classification: Pump, infusion - Product Code FRN
• Product: 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 modules are indicated for use on adults, pediatrics and neonates for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous, subcutaneous or epidural. The Alaris Syringe pump and PCA modules can be connected to the Alaris PC unit which is the central programming, monitoring, and power supply component for the Alaris System. The syringe pump and PCA pump uses standard, plastic piston syringes and single-use administration sets with luer-lock connectors.
• Code Information: UDI 10885403810015. Product involved are those devices manufactured and/or serviced between 5/1/2013 through 4/30/2017.
• Recalling Firm/ Manufacturer: CareFusion 303, Inc.; 10020 Pacific Mesa Blvd; San Diego CA 92121-4386
• For Additional Information Contact: Michelle Badal; 858-617-5977
• Manufacturer 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The recalling firm issued "Medical Device Safety Notification, dated November 17, 2017, via UPS. The letter describes the potential issue, affected products, potential risks, and required action for the users. The actions noted that clinicians can continue to use the device and follow the Alaris System User Manual for proper loading of the syringe. Per the manual, clinicians should ensure the plunger grippers lock and hold the syringe plunger in place. The Biomedical Engineering can detect if the device has this issue and if the issue described occurs, the user is to contact BD Support Center or email them to schedule service of the device at the BD Service Depot. Enclosed with the notification letter was a list of affected serial numbers, an excerpt from the user manual to "Prepare Syringe and Administration Set (Syringe Module)", and a customer response card to be returned via mail, email or FAX to confirm the notification has been received. For further questions, please call (858) 617-5977.
• Quantity in Commerce: 73,611
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN and Original Applicant = ALARIS MEDICAL SYSTEMS, INC.