CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring...
FDA Device Recall #Z-0528-2021 — Class II — July 30, 2020
Recall Summary
| Recall Number | Z-0528-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 30, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | CME America, LLC |
| Location | Golden, CO |
| Product Type | Devices |
| Quantity | Total pumps = 4,182 (all models) |
Product Description
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).
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.
Distribution Pattern
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.
Lot / 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
Other Recalls from CME America, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0530-2021 | Class II | CME America T-Syringe Pump - T34 - Product Usag... | Jul 30, 2020 |
| Z-0526-2021 | Class II | CME America T-Syringe Pump - NeoThrive - Produc... | Jul 30, 2020 |
| Z-0529-2021 | Class II | CME America T-Syringe Pump - Ameritus 1st Enter... | Jul 30, 2020 |
| Z-0527-2021 | Class II | CME America T-Syringe Pump - T34L PCA - Product... | Jul 30, 2020 |
| Z-0525-2021 | Class II | CME America T-Syringe Pump -T34L - Product Usag... | Jul 30, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.