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U.S. Department of Health and Human Services

Class 2 Device Recall Medfusion Syringe Infusion Pump

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  Class 2 Device Recall Medfusion Syringe Infusion Pump see related information
Date Initiated by Firm April 13, 2018
Create Date August 08, 2018
Recall Status1 Terminated 3 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/
Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact
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 2
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.