CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or…
Medical device recall Z-0525-2021. 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 -T34L - 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 TR34L - Part Number(s) 100-100PSLA; 100-101PSLA Serial Number: 58766 58765 26479 69547 69548 26428 26299 26301 26295 26294 26304 26296 26298 26302 26297 26300 26130 26133 26132 58906 58907 58909 58910 58911 58912 58913 58914 58915…
Every code shown here, 1,045 characters
Model TR34L - Part Number(s) 100-100PSLA; 100-101PSLA Serial Number: 58766 58765 26479 69547 69548 26428 26299 26301 26295 26294 26304 26296 26298 26302 26297 26300 26130 26133 26132 58906 58907 58909 58910 58911 58912 58913 58914 58915 58916 58917 58918 58919 58920 58921 58922 58923 58924 58925 58926 58998 59003 59007 58999 59006 59000 59004 59002 59005 59001 69618 69619 69628 69629 69630 69637 69659 69666 69638 69579 70119 70134 70136 70142 70144 70145 70146 70147 70148 70162 70167 70169 70172 70173 70174 70175 70143 S25610 S25720 S25725 S25729 S69776 S69785 S70157 S70160 S70165 S70176 S70192 S70203 S70206 S70207 S70208 S70209 S70210 S70211 S70129 S70177 S70181 S70205 S70114 S70115 S70117 S70118 S70120 S70121 S70124 S70125 S70126 S70127 S70128 S70130 S70131 S70132 S70138 S70139 S70140 S70163 S70164 S70166 S70182 S70183 S70185 S70187 S70188 S70190 S70191 S70194 S70195 S70196 A12200 A12201 S69760 A100795 A100796 A100797 A100798 A100799 A100800 A100801 A100802 A100803 UDI Code: B101100100PSLA0 100-101 PSLA was retired prior to UDI
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.