Prometra II Programmable Pump
Medical device recall Z-1715-2019. 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
- 6445 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. Error 115 can also occur if dendrites form or if the pump is dropped.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion.
6445, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 10AA4A01X 10BC4A84X 10CC4C06X 10EB4A27X 10GB4A05X 10HA4E28X 10IA4B69X 10JA4B52X 10KB4A76X 10AA4A02X 10BC4A86X 10CC4C07X 10EB4A28X 10GB4A07X 10HA4E29X 10IA4B70X 10JA4B53X 10KB4A77X 10AA4A03X 10BC4A87X 10CC4C08X 10EB4A29X…
Every code shown here, 1,996 characters
Serial Numbers: 10AA4A01X 10BC4A84X 10CC4C06X 10EB4A27X 10GB4A05X 10HA4E28X 10IA4B69X 10JA4B52X 10KB4A76X 10AA4A02X 10BC4A86X 10CC4C07X 10EB4A28X 10GB4A07X 10HA4E29X 10IA4B70X 10JA4B53X 10KB4A77X 10AA4A03X 10BC4A87X 10CC4C08X 10EB4A29X 10GB4A08X 10HA4E30X 10IA4B71X 10JA4B54X 10KB4A78X 10AA4A04X 10BC4A88X 10CC4C09X 10EB4A30X 10GB4A10X 10HA4E31X 10IA4B72X 10JA4B55X 10KB4A79X 10AA4A05X 10BC4A89X 10CC4C10X 10EB4A31X 10GB4A11X 10HB4A01X 10IA4B73X 10JA4B56X 10KB4A80X 10AA4A06X 10BC4A90X 10CC4C11X 10EB4A33X 10GB4A13X 10HB4A02X 10IA4B74X 10JA4B57X 10KB4A81X 10AA4A07X 10BC4A92X 10CC4C12X 10EB4A34X 10GB4A14X 10HB4A03X 10IA4B75X 10JA4B58X 10KB4A82X 10AA4A08X 10BC4A94X 10CC4C13X 10EB4A35X 10GB4A15X 10HB4A04X 10IA4B76X 10JA4B59X 10KB4A84X 10AA4A09X 10BC4A96X 10CC4C14X 10EB4A36X 10GB4A17X 10HB4A05X 10IB4A31X 10JA4B60X 10KB4A86X 10AA4A10X 10BC4A97X 10CC4C15X 10EB4A39X 10GB4A18X 10HB4A06X 10IB4A32X 10JA4B61X 10KB4A87X 10AA4A11X 10BC4A98X 10CC4C16X 10EB4A40X 10GB4A19X 10HB4A07X 10IB4A33X 10JB4A01X 10KB4A88X 10AA4A12X 10BC4A99X 10CC4C17X 10EB4A41X 10GB4A20X 10HB4A08X 10IB4A34X 10JB4A02X 10KB4A89X 10AA4A13X 10BC4B01X 10CC4C18X 10EB4A42X 10GB4A21X 10HB4A09X 10IB4A35X 10JB4A03X 10KB4A90X 10AA4A14X 10BC4B02X 10CC4C19X 10EB4A43X 10GB4A22X 10HB4A10X 10IB4A36X 10JB4A04X 10KB4A91X 10AA4A15X 10BC4B04X 10CC4C20X 10EB4A44X 10GB4A23X 10HB4A11X 10IB4A38X 10JB4A05X 10KB4A93X 10AA4A16X 10BC4B05X 10CC4C21X 10EB4A45X 10GB4A24X 10HB4A12X 10IB4A39X 10JB4A06X 10KB4A94X 10AA4A17X 10BC4B06X 10CC4C22X 10EB4A46X 10GB4A27X 10HB4A13X 10IB4A40X 10JB4A07X 10KB4A95X 10AA4A18X 10BC4B07X 10CC4C23X 10EB4A47X 10GB4A28X 10HB4A14X 10IB4A41X 10JB4A08X 10KB4A96X 10AA4A19X 10BC4B08X 10CC4C24X 10EB4A48X 10GB4A29X 10HB4A15X 10IB4A42X 10JB4A09X 10KB4A97X 10AA4A20X 10BC4B09X 10CC4C25X 10EB4A49X 10GB4A30X 10HB4A16X 10IB4A43X 10JB4A10X 10KB4A99X 10AA4A32X 10BC4B22X 10CC4C37X 10EB4A63X 10GB4A44X 10HB4A28X 10IB4A58X 10JB4A23X 10KB4B18X 10AA4A33X 10BC4B24X 10CC4C38X 10EB4A64X 10GB4A45X 10HB4A29X 10IB4A59X 10JB4A24X 10KB4B19X…
FDA’s list runs to 63,476 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 63,476 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.