Class 2 Device Recall Medfusion Syringe Infusion Pump

• Date Initiated by Firm: April 13, 2018
• Create Date: August 08, 2018
• Recall Status: Terminated on January 30, 2023
• Recall Number: Z-2662-2018
• Recall Event ID: 80490
• 510(K)Number: K111386 K040899
• Product Classification: Pump, infusion - Product Code FRN
• Product: Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
• Code Information: Barrel Clamp Guide mechanism number: G6000716; Barrel Clamp Guide lot numbers: P0239588, P0321444, and P0462421
• Recalling Firm/ Manufacturer: Smiths Medical ASD Inc.; 6000 Nathan Ln N; Minneapolis MN 55442-1690
• For Additional Information Contact: 763-383-3072
• Manufacturer Reason for Recall: Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe.
• FDA Determined Cause: Process change control
• Action: Customers were notified of the recall on about 04/13/2018 via URGENT MEDICAL DEVICE RECALL NOTICE letter. Instructions included to evaluate current inventory for affected Barrel Clamp Guide, review and complete the Recall Response Form, return affected Barrel Clamp Guides to Stericycle for destruction, and if the affected Barrel Clamp Guides have already been installed in pumps, continue to use the pumps, but utilize the Syringe Verification Reference Tool provided with the Recall Notice until the pumps are repaired. Customers were also instructed to notify customers if the affected devices were further distributed. Questions regarding the recall can be directed to Stericycle at SmithsMedical5120@stericycle.com.
• Quantity in Commerce: 276 units
• Distribution: US distribution to AL, AZ, CA, DC, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, WA. International distribution to Canada and Lebanon.
• 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 = MEDEX, INC.; 510(K)s with Product Code = FRN and Original Applicant = SMITHS MEDICAL MD, INC.