Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported February 19, 2020
Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
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 to…
Flowonix Medical Inc recalled Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN… - a moderate-severity action.
Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN… was recalled by Flowonix Medical Inc in February 19, 2020. Reason: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error…. Check the official notice for the remedy. Verify recall #Z-1122-2020 with the FDA Devices before acting.
The recall
Flowonix Medical Inc issued this moderate-severity FDA Devices recall-A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error….
- Moderate
- severity level
- Class II
- classification
- February 19, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1122-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1122-2020) was formally reported on February 19, 2020, with the manufacturer initiating the action on December 24, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. Flowonix Medical Inc is listed as the recalling firm, operating out of Mansfield, MA. Federal records list the affected scope as 6670 (US).
The documented reason for this recall is: 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" conditi… Distribution data in the federal record shows the product reached: Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
6670 (US)
Related Recalls
6
3 from same agency
Product description
Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1122-2020 |
| Date reported | February 19, 2020 |
| Date initiated | December 24, 2019 |
| Recalling firm | Flowonix Medical Inc |
| Firm location | Mansfield, MA |
| Affected scope | 6670 (US) |
| Distribution | Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1122-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242. Recalled by Flowonix Medical Inc. Units affected: 6670 (US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 19, 2020. Severity: Moderate. Recall number: Z-1122-2020.
Where was the recalled product distributed? ▼
Distribution: Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1122-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 19, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.