CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids…
Medical device recall Z-0529-2021. 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 - Ameritus 1st Enteral Pump - 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 Ameritus 1st Enteral Pump - Part Number(s) AEG-1PUMP Serial Number: 58791 58770 58769 58768 58760 26417 26480 26481 26482 26483 26466 26467 26468 26469 26470 26471 26472 26473 26474 26475 26476 26477 26453 26454 26457 26448 26452…
Every code shown here, 1,752 characters
Model Ameritus 1st Enteral Pump - Part Number(s) AEG-1PUMP Serial Number: 58791 58770 58769 58768 58760 26417 26480 26481 26482 26483 26466 26467 26468 26469 26470 26471 26472 26473 26474 26475 26476 26477 26453 26454 26457 26448 26452 26449 26458 26455 26451 26459 26450 26445 26446 26440 26441 26427 26419 26420 26421 26422 26423 26424 26425 26426 26411 26413 26414 26416 26283 26284 26285 26286 26287 26288 26289 26290 26291 26292 26293 26281 26282 26252 26255 26254 26257 26250 26251 26256 26253 26249 26248 26267 26242 26243 26244 26245 26246 26247 26212 26215 26216 26217 26218 26219 26220 26221 26222 26223 26224 26225 26226 26227 26228 26229 26230 26231 26232 26233 26234 26235 26236 26237 26238 26239 26240 26162 26165 26166 26167 26169 26170 26172 26175 26176 26177 26180 26181 26182 26183 26184 26186 26163 26164 26168 26171 26173 26174 26178 26179 26185 26095 26100 26098 26062 26102 26109 26101 26069 26067 26020 26018 26019 26064 26093 26085 26099 26096 26097 26094 26090 26089 26092 26086 26111 26106 26060 26066 26063 26059 26065 26123 26119 26076 26083 26121 26080 26079 26078 26091 26105 26104 26103 26108 26112 26122 26126 26118 26082 26127 26072 26113 26107 26114 26110 26071 26081 26117 26075 26116 26073 26115 26074 26070 26120 26125 26026 26032 26029 26030 26027 26021 58811 58813 58814 58815 58816 58817 58818 58819 58821 58822 58823 58826 58827 58830 58927 58928 58929 58930 58931 58932 69790 69791 69792 69793 69794 69795 69796 69797 69798 69800 69802 69803 69805 69806 69807 69808 69809 69810 69811 69812 69813 69814 69874 69875 69876 69878 69879 69881 69882 A100156 A100157 A100158 S69877 S69880 S69883 S70112 S70122 S70123 S70133 S70135 S70137 S70156 S70171 S70179 S70180 S70197 S70199 S70200 S70201 UDI Code: B101AEG1PUMP0
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.