Prometra Clinician Programmer (Touchscreen) Software version 2.00.29
Medical device recall Z-1712-2019. Published in FDA’s Enforcement Report on Jun 12, 2019.
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 Jun 12, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 318 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?
The pump shuts down unexpectedly if Error 115, an alarm associated with a watchdog timer timeout, is triggered. There has been an increase of Error 115 occurrences due to a software defect caused by a Healthcare Provider using a Clinician Programmer, Software Version 2.00.29, to program a Bridge or Demand bolus while the pump is set to either a Periodic Flow or Multiple Rates flow mode.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
318, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: A15E0017 A15J0019 A16D0004 RA17B0003 RA17I0001 RA18B0008 RA18D0046 RA18G0074 RA18J0074 A15E0023 A15J0035 A16D0013 RA17B0004 RA17I0002 RA18B0009 RA18D0047 RA18G0079 RA18J0077 A15E0032 A15J0038 A16D0015 RA17B0007 RA17I0003…
Every code shown here, 1,999 characters
Serial Numbers: A15E0017 A15J0019 A16D0004 RA17B0003 RA17I0001 RA18B0008 RA18D0046 RA18G0074 RA18J0074 A15E0023 A15J0035 A16D0013 RA17B0004 RA17I0002 RA18B0009 RA18D0047 RA18G0079 RA18J0077 A15E0032 A15J0038 A16D0015 RA17B0007 RA17I0003 RA18B0012 RA18D0048 RA18G0080 RA18J0078 A15H0003 A15J0047 A16D0018 RA17C0001 RA17I0004 RA18B0014 RA18D0052 RA18J0001 RA18J0081 A15H0007 A15J0050 A16D0026 RA17C0005 RA17I0005 RA18B0016 RA18D0053 RA18J0002 RA18J050 A15H0031 A15J0051 A16D0032 RA17C0006 RA17I0007 RA18B0018 RA18G0004 RA18J0003 RA18K0003 A15H0038 A15K0018 A16D0033 RA17C0007 RA17I0008 RA18B0020 RA18G0005 RA18J0004 RA18K0004 A15H0039 A15K0036 A16D0036 RA17C0025 RA17I0010 RA18B0023 RA18G0006 RA18J0009 RA18K0007 A15H0054 A15K0042 A16D0037 RA17C0028 RA17I0012 RA18B0026 RA18G0007 RA18J0011 RA18K0008 A15H0067 A15K0045 A16D0039 RA17C0038 RA17I0021 RA18B0027 RA18G0010 RA18J0012 RA18K001 A15I0005 A15K0046 A16D0040 RA17C0039 RA17I0024 RA18B0030 RA18G0011 RA18J0013 RA18K0010 A15I0015 A15K0053 A16D0042 RA17C0041 RA17J0003 RA18B0033 RA18G0012 RA18J0014 RA18L0001 A15I0019 A15K0055 A16D0046 RA17F0006 RA17J0004 RA18B0036 RA18G0017 RA18J0015 RA18L0002 A15I0020 A15L0003 A16D0047 RA17F0007 RA17J0005 RA18B0037 RA18G0021 RA18J0016 RA18L0004 A15I0039 A15L0029 A16D0049 RA17F0008 RA17J0008 RA18B0040 RA18G0022 RA18J0019 RA18L0007 A15I0043 A15L0067 A16D0051 RA17F0009 RA17J0011 RA18B0042 RA18G0023 RA18J0021 RA18L0010 A15I0046 A15L0068 A16D0058 RA17F0011 RA17J0016 RA18B0047 RA18G0025 RA18J0022 RA18L019 A15I0049 A15L0069 A16D0073 RA17F0012 RA17K0002 RA18B0053 RA18G0026 RA18J0023 RA18L020 A15I0058 A15L0070 A16D0074 RA17F0018 RA17K0008 RA18B0055 RA18G0027 RA18J0025 RA18L021 A15I0062 A16B0002 A17C0011 RA17F0024 RA17K0009 RA18C0003 RA18G0031 RA18J0030 RA18L022 A15I0067 A16B0003 A17D0009 RA17F0025 RA17L0001 RA18D0002 RA18G0032 RA18J0031 RA18L023 A15I0068 A16B0008 A17D0010 RA17F0028 RA17L0002 RA18D0003 RA18G0033 RA18J0034 RA18L024 A15I0070 A16C0006 A17E0003 RA17F0030 RA17L0003 RA18D0006 RA18G0040 RA18J0038…
FDA’s list runs to 3,072 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.
US nationwide distribution.
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.
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 Mar 21, 2019.
- FDA classified it on Jun 3, 2019.
- FDA’s Enforcement Report published it on Jun 12, 2019.
- FDA terminated it on Jun 5, 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: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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 3,072 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.