CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or…
Medical device recall Z-0530-2021. 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 - T34 - 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 T34 - Part Number(s) 100-100PS; 100-100PSA; 100-100POBSC; 100-101PS Serial Number: 58771 58772 58773 58774 58775 58776 58777 58778 58779 58780 58781 58782 58783 58784 58785 58786 58787 58788 58789 58790 26478 S26442 S26443 S26444…
Every code shown here, 2,000 characters
Model T34 - Part Number(s) 100-100PS; 100-100PSA; 100-100POBSC; 100-101PS Serial Number: 58771 58772 58773 58774 58775 58776 58777 58778 58779 58780 58781 58782 58783 58784 58785 58786 58787 58788 58789 58790 26478 S26442 S26443 S26444 26305 26307 26309 26310 26311 26312 26313 26314 26315 26316 26317 26318 26319 26320 26321 26322 26335 26323 26324 26325 26326 26327 26328 26329 26330 26331 26332 26333 26334 26336 26337 26338 26339 26340 26341 26342 26343 26344 26345 26346 26347 26348 26349 26350 26351 26352 26353 26354 26355 26356 26357 26358 26360 26361 26362 26363 26364 26365 26366 26367 26368 26369 26370 26371 26372 26373 26374 26375 26376 26377 26378 26379 26380 26381 26382 26383 26384 26386 26387 26388 26389 26390 26391 26392 26393 26394 26395 26396 26397 26398 26399 26400 26401 26402 26404 26405 26407 26408 S26261 S26262 S26263 S26264 S26265 S26266 26139 26140 26137 26141 26138 26146 26142 26144 26145 26143 26147 26151 26148 26149 26150 25923 25924 25925 25926 25927 82572 82580 A100488 A100526 A100527 A100514 A100493 A100535 A100531 A100519 A100505 A100492 A100496 A100490 A100501 A100522 A100524 A100513 A100529 A100528 A100533 A100518 A100507 A100497 A100495 A100500 A100503 A100489 A100523 A100515 A100512 A100537 A100530 A100534 A100521 A100510 A100498 A100509 A100499 A100504 A100525 A100516 A100511 A100536 A100532 A100517 A100520 A100508 A100506 A100491 A100502 A100494 A100152 A100153 A100154 A100155 58852 58854 58855 58856 58857 58858 58860 58861 58862 58863 58864 58865 58866 58867 58868 58869 58870 58871 58872 58873 58874 58875 58876 58877 58878 58880 58882 58883 58885 58886 58887 58888 58889 58890 58891 58892 58893 58895 58896 58897 58898 58899 58900 58901 58902 58903 58904 58945 58946 58947 58948 58949 58950 58952 58953 58954 58955 58957 58958 58959 58960 58962 58963 58964 58965 58966 58967 58968 58969 58970 58971 58972 58973 58974 58975 58976 58977 58978 58979 58980 58981 58982 58983 58984 58985 58986 58987 58988 58989 58990 58991 58993 58994 58995 69596…
FDA’s list runs to 9,781 characters. The first part is shown; the rest is on FDA’s record.
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.”
- FDA’s list of codes runs to 9,781 characters; the first part is shown here, and the rest is on FDA’s record.
- 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
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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.