Class 2 Device Recall CME America TSyringe Pump

• Date Initiated by Firm: July 30, 2020
• Create Date: December 03, 2020
• Recall Status: Terminated on March 08, 2022
• Recall Number: Z-0528-2021
• Recall Event ID: 86047
• 510(K)Number: K080954
• Product Classification: Pump, infusion - Product Code FRN
• Product: CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
• Code Information: Model Neofeed - Part Number(s) 100-109PSL1A; 100-109PSLA; 100-110PSLA UDI Codes: B101100109PSLA0 B101100109SL1A0 B101100110PSLA0 Serial Number: 58767 58763 58761 26410 26439 26447 26456 26460 26461 26462 26463 26464 26465 26158 26157 26159 26160 26161 26134 26135 23136 26047 26008 26055 26054 26053 26048 26036 26050 26031 26035 26028 26007 26022 26014 26033 26012 26005 26023 26002 26000 26024 26034 25998 26010 26001 26009 26003 26015 26004 26006 26016 25930 25931 25932 25933 25938 25939 25960 25961 25962 25963 25964 25965 25966 25967 25969 25970 25971 25972 25973 25974 25975 25976 25977 25978 25979 25980 25981 25982 25983 25984 25985 25986 25987 25988 25989 25990 25991 25992 25993 25995 25996 25936 25935 25947 25968 25956 25949 25943 25954 25948 25934 25951 25945 25944 25953 25946 25952 25959 25957 25950 25958 25941 25955 25942 25937 25901 25903 25897 25900 25919 25839 25836 25880 25882 25874 25852 25884 25881 25883 25838 25916 25922 25912 25917 25913 25915 25914 25907 25921 25918 25909 25920 25908 25928 25929 25899 25910 25898 25911 25905 25894 25902 25904 25896 25906 25831 25834 25837 25840 25842 25843 25844 25847 25850 25855 25856 25857 25858 25859 25861 25862 25864 25865 25866 25867 25868 25869 25870 25871 25872 25873 25885 25886 25887 25888 25889 25890 25891 25892 25893 25895 25863 25846 25854 25853 25824 25851 25849 25860 25841 25845 25828 25833 25830 25832 25825 25827 25823 25826 25829 25835 25879 25878 25877 25875 25876 25848 25699 25700 25698 25815 25805 25822 25806 25809 25807 25821 25812 25808 25820 25810 25817 25811 S70178 S70198 S70202 S70204 S70116 S70152 S70153 S70154 S70159 S70161 S70155 S70212 S70158
• Recalling Firm/ Manufacturer: CME America, LLC; 14998 W 6th Ave Ste 830; Golden CO 80401-5025
• For Additional Information Contact: Customer/Technical Support; 303-936-4945
• Manufacturer Reason for Recall: Multiple reasons: 1) Due to wear and tear of pump motor block mechanism - may cause under infusion situations without the pump alarm being generated. 2) Due to cracks, pump hardware may be damaged by fluid used during the cleaning process.
• FDA Determined Cause: Other
• Action: On July 30, 2020, the firm sent an "URGENT MEDICAL DEVICE RECALL CORRECTION" Notification Letter via FedEx to customers informing them of two issues: Issue 1: The motor block mechanism may be affected over time by normal wear and tear which may cause the device to stop without alarms being generated. Issue 2: Due to routine cleaning and disinfection, there is a potential for fluid to ingress into the pump and over time, could result in damage to the pump components leading to inoperability of the device. For this issue the device will stop and will alarm. The Recalling Firm is instructing customers to: For Issue 1: Inspect the lead screw to detect the presence of white plastic debris. Inspection must be performed prior to each use of the affected pumps. If signs of wear and tear are observed, discontinue use of the pump and contact the Recalling Firm for product removal. For Issue 2: Follow the Manufacturer Recommended Cleaning instructions in Appendix A and the Technical Service Manual instructions for preventive maintenance provided in Appendix B of the attached Customer Letter to limit the cumulative effects of fluid ingress over time. Immediate Actions to Take: 1) Please refer to the attached customer communication regarding this recall action. 2) As the Recalling Firm plans to notify all affected customers directly, customers are asked to identify customers within their distribution network that purchased the affected product, as defined in the recall notification. Email an excel file listing of all customers to BDRC12@bd.com within 72 hours of receipt of this letter so that the Recalling Firm may initiate customer notification. 3) Complete the attached Distributor Response Form and return to the Recalling Firm's contact noted on the form whether or not the customers have any of the impacted material so that the Recalling Firm may acknowledge the receipt of this notification. 4) Contact the Recalling Firm to arrange for the return of all in sto
• Quantity in Commerce: Total pumps = 4,182 (all models)
• Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, AK, CA, CO, CT, FL, ID, IL, KS, LA, MA, MI, MO, MT, NC, NE, NV, Oh, OK, OR, PA, TN, TX, WA, and WI. The country of Canada.
• 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 = CAESAREA MEDICAL ELECTRONICS LTD.