Prometra II 20mL Pump
Medical device recall Z-1121-2020. Published in FDA’s Enforcement Report on Feb 19, 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 Feb 19, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 6670 (US) 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?
A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain “out of tolerance” conditions associated with the pump’s valve system.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
6670 (US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers 10HW4A31 10AZ4A69X 10AZ4A07X 10BZ4A16X 10BZ4A61X 10BZ4A41X 10AZ4A48X 10AZ4A50X 10AZ4A23X 10AZ4A36X 10AZ4A42X 10BZ4A37X 10BZ4A64X…
Every code shown here, 1,993 characters
All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers 10HW4A31 10AZ4A69X 10AZ4A07X 10BZ4A16X 10BZ4A61X 10BZ4A41X 10AZ4A48X 10AZ4A50X 10AZ4A23X 10AZ4A36X 10AZ4A42X 10BZ4A37X 10BZ4A64X 10BZ4A12X 10CZ4B09X 10CZ4A95X 10CZ4B22X 10BZ4A18X 10CZ4A79X 10CZ4A86X 10CZ4A96X 10CZ4A88X 10CZ4A80X 10CZ4A85X 10CZ4A81X 10CZ4A82X 10CZ4A78X 10CZ4A91X 10CZ4A94X 10CZ4A90X 10CZ4A77X 10CZ4B28X 10CZ4B05X 10CZ4B15X 10CZ4B21X 10CZ4A87X 10CZ4B32X 10AZ4A41X 10CZ4B23X 10CZ4A93X 10CZ4B01X 10CZ4B17X 10CZ4B04X 10CZ4B30X 10BZ4A55X 10CZ4B08X 10CZ4A76X 10CZ4B33X 10CZ4B20X 10DZ4A01X 10DZ4A58X 10DZ4A19X 10CZ4B36X 10CZ4A84X 10DZ4A18X 10CZ4B24X 10DZ4A76X 10BZ4A30X 10CZ4B26X 10BZ4A09X 10DZ4A51X 10DZ4A93X 10DZ4A32X 10CZ4B03X 10DZ4A89X 10BZ4A11X 10DZ4A30X 10CZ4B25X 10DZ4A65X 10DZ4A05X 10DZ4A98X 10DZ4A08X 10DZ4A42X 10DZ4A77X 10CZ4A92X 10DZ4A35X 10DZ4A80X 10DZ4A92X 10DZ4A88X 10DZ4A07X 10BZ4A39X 10DZ4A73X 10DZ4A53X 10DZ4A28X 10DZ4A84X 10DZ4A45X 10CZ4B14X 10DZ4A40X 10DZ4A72X 10DZ4A64X 10DZ4A79X 10DZ4A60X 10DZ4A82X 10DZ4A37X 10DZ4B39X 10DZ4A54X 10DZ4A67X 10CZ4B29X 10BZ4A59X 10DZ4A20X 10DZ4A38X 10DZ4B04X 10DZ4A36X 10DZ4A91X 10DZ4B37X 10DZ4B06X 10DZ4A34X 10DZ4A25X 10DZ4B24X 10DZ4B49X 10DZ4B38X 10CZ4A89X 10DZ4B05X 10DZ4A15X 10DZ4A43X 10DZ4B54X 10BZ4A25X 10DZ4A66X 10DZ4B53X 10DZ4A29X 10DZ4A23X 10DZ4B08X 10DZ4A21X 10DZ4B40X 10DZ4A83X 10DZ4A17X 10DZ4A62X 10DZ4B19X 10DZ4B46X 10EZ4A36X 10DZ4B16X 10DZ4A87X 10DZ4B25X 10DZ4B43X 10DZ4B10X 10DZ4B61X 10DZ4B50X 10DZ4B07X 10DZ4B48X 10DZ4B26X 10DZ4B29X 10DZ4A27X 10CZ4B27X 10EZ4A02X 10DZ4B22X 10DZ4B15X 10EZ4A46X 10EZ4A27X 10EZ4A01X 10DZ4A47X 10DZ4A81X 10DZ4A33X 10EZ4A30X 10EZ4A26X 10EZ4A51X 10DZ4B03X 10EZ4A37X 10EZ4A13X 10EZ4A39X 10EZ4A35X 10DZ4B45X 10EZ4A28X 10DZ4A10X 10FZ4A34X 10CZ4B35X 10EZ4A09X 10EZ4A43X 10EZ4A05X 10EZ4A17X 10EZ4A16X 10DZ4B21X 10DZ4A94X 10EZ4A19X 10EZ4A45X 10DZ4A44X 10DZ4A68X 10EZ4A25X 10FZ4A29X 10EZ4A32X 10DZ4A48X 10FZ4A24X 10EZ4A18X 10DZ4B55X 10DZ4A06X 10FZ4A02X 10EZ4A57X 10EZ4A24X 10EZ4A58X 10EZ4A06X…
FDA’s list runs to 62,563 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.
Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.
These words name no state.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Dec 24, 2019.
- FDA classified it on Feb 10, 2020.
- FDA’s Enforcement Report published it on Feb 19, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Flowonix Medical Inc, of Mansfield, MA.
- 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 62,563 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.