Prometra Programmable 20mL Pump
Medical device recall Z-1120-2020. 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 Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082
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 10JW4A32 10HW4A29 10JW4A44 10JW4A35 10HW4A45 10JW4A05 10JW4A08 10JW4A46 10JW4A36 10JW4A30 10JW4A39 10JW4A06 10JW4A21 10JW4A01 10JW4A27…
Every code shown here, 1,996 characters
All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers 10JW4A32 10HW4A29 10JW4A44 10JW4A35 10HW4A45 10JW4A05 10JW4A08 10JW4A46 10JW4A36 10JW4A30 10JW4A39 10JW4A06 10JW4A21 10JW4A01 10JW4A27 10KW4A47 10JW4A29 10JW4A41 10KW4A122 10JW4A02 10KW4A05 10JW4A25 10KW4A38 10KW4A61 10KW4A11 10KW4A16 10KW4A27 10KW4A08 10KW4A117 10KW4A68 10KW4A99 10KW4A91 10KW4A20 10KW4A53 10KW4A106 10KW4A02 10JW4A20 10KW4A35 10KW4A18 10KW4A101 10AX4A21 10JW4A43 10KW4A73 10KW4A123 10KW4A67 10AX4B27 10KW4A31 10KW4A24 10AX4A37 10KW4A83 10AX4A36 10AX4A22 10AX4A10 10KW4A42 10KW4A119 10AX4B24 10KW4A89 10KW4A71 10KW4A116 10AX4A12 10DX4A79 10DX4A10 10AX4B06 10AX4B09 10DX4A95 10AX4A81 10AX4A98 10KW4A103 10AX4A96 10AX4A95 10AX4B82 10AX4A76 10KW4A48 10HY4C42 10KW4A09 10AX4A88 10DX4A32 10AX4A87 10AX4B92 10GX4B05 10GX4A30 10KW4A104 10AX4A14 10DX4A98 10GX4B21 10AX4A85 10KW4A85 10KW4A06 10AX4A73 10GX4A21 10GX4A09 10DX4A85 10GX4A82 10JW4A31 10GX4A87 10JW4A16 10GX4A85 10KW4A12 10GX4B16 10KW4A43 10GX4A34 10GX4A83 10AX4B78 10GX4B03 10GX4A38 10GX4B08 10KW4A29 10GX4B07 10KW4A30 10GX4A32 10AX4B90 10GX4A70 10AX4B81 10AX4B53 10GX4A92 10KY4A20 10KW4A52 10KW4A39 10GX4A19 10GX4A96 10DX4A21 10KX4A02 10DX4B07 10KX4A12 10KX4A15 10KW4A75 10GX4A99 10KX4A43 10GX4A45 10KX4A40 10KX4A41 10DX4A09 10DX4A74 10DX4A48 10KX4A42 10GX4A97 10GX4A10 10AX4B80 10KX4A59 10JW4A04 10KW4A44 10GX4A73 10KX4A14 10KX4A13 10GX4B15 10KX4A70 10KX4A57 10KX4A74 10KW4A25 10GX4A03 10GX4A63 10GX4A71 10KW4A108 10KX4A85 10KW4A105 10GX4A40 10GX4A14 10DX4A33 10BY4A40 10BY4A51 10BY4A39 10KX4A62 10BY4A25 10BY4A59 10BY4A36 10EY4A53 10KX4A10 10KX4A39 10EY4A27 10KX4A26 10EY4A26 10BY4A60 10EY4A38 10KX4A80 10BY4A57 10EY4A17 10EY4A83 10EY4A03 10BY4A48 10EY4A25 10EY4A29 10EY4A88 10EY4A99 10EY4A59 10EY4A05 10EY4A82 10EY4A19 10EY4A67 10EY4A89 10BY4A52 10KX4A17 10EY4A36 10EY4A58 10EY4A73 10EY4A43 10GX4A12 10KX4A78 10EY4A15 10BY4A34 10GY4A63 10EY4A37 10EY4A98 10KX4A25 10BY4A30 10GY4A16 10EY4A48 10KX4A76 10GY4A11 10GY4A19…
FDA’s list runs to 3,652 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 3,652 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
-
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.