CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous…
Medical device recall Z-0528-2021. Published in FDA’s Enforcement Report on Dec 9, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 9, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 24 states named
- Total pumps = 4,182 (all models) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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).
Total pumps = 4,182 (all models), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,644 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
24 states and territories.
Every one of them
- Alaska
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Idaho
- Illinois
- Kansas
- Louisiana
- Massachusetts
- Michigan
- Missouri
- Montana
- North Carolina
- Nebraska
- Nevada
- Oklahoma
- Oregon
- Pennsylvania
- Tennessee
- Texas
- Washington
- Wisconsin
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 30, 2020.
- FDA classified it on Dec 3, 2020.
- FDA’s Enforcement Report published it on Dec 9, 2020.
- FDA terminated it on Mar 8, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- CME America, LLC, of Golden, CO.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.