Reported Feb 19, 2020 · Ongoing
Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
Flowonix Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Flowonix Medical Inc · 120 Forbes Blvd Ste 170 · Mansfield, MA · 02048-1150
Is this the product you have?
- Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
- Lot codes and dates
- All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers
2,954 of 2,954 codes
10HW4A3110AZ4A69X10AZ4A07X10BZ4A16X10BZ4A61X10BZ4A41X10AZ4A48X10AZ4A50X10AZ4A23X10AZ4A36X10AZ4A42X10BZ4A37X10BZ4A64X10BZ4A12X10CZ4B09X10CZ4A95X10CZ4B22X10BZ4A18X10CZ4A79X10CZ4A86X10CZ4A96X10CZ4A88X10CZ4A80X10CZ4A85X10CZ4A81X10CZ4A82X10CZ4A78X10CZ4A91X10CZ4A94X10CZ4A90X10CZ4A77X10CZ4B28X10CZ4B05X10CZ4B15X10CZ4B21X10CZ4A87X10CZ4B32X10AZ4A41X10CZ4B23X10CZ4A93X10CZ4B01X10CZ4B17X10CZ4B04X10CZ4B30X10BZ4A55X10CZ4B08X10CZ4A76X10CZ4B33X10CZ4B20X10DZ4A01X10DZ4A58X10DZ4A19X10CZ4B36X10CZ4A84X10DZ4A18X10CZ4B24X10DZ4A76X10BZ4A30X10CZ4B26X10BZ4A09X
- All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers
- Amount recalled
- 6670 (US)
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Flowonix Medical Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.