CLASS II ONGOING Device recall · Reported 19 Feb 2020 · FDA Enforcement Report

US Clinical Programmable Pump recalled by Flowonix Medical

Flowonix Medical is recalling US Clinical Programmable Pump, distributed nationwide in the US. The recall was initiated on 24 Dec 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers 10HW4A57 10AX4A06 36ES4A15 36AR4A04 36AR4A06 36AR4A13 36HS4A10 36HS4A54 36JN4A04 36JN4A06 36JN4A07 36JN4A09 36JN4A13 36JN4A14 36JN4A15 36JN4A18 36JN4A23 36JN4A28 36JN4A35 36KN4A11 36KN4A16 36KN4A23 36KN4A27 36KN4A33 36KN4A34 36KN4A41 36HS4A01 10IT4A21 36HS4A14 36HS4A26 36BS4A17 36ES4A28 36ES4A33 36ES4A08 10IT4A16 36FR4A13 36HS4A61 10ET4A07 36HS4A46 10ET4A20 36HS4A25 36HS4A43 10ET4A02

Quantity recalled6670 (US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1123-2020
FDA event ID: 84653
Recalling firm: Flowonix Medical, Mansfield, MA
Classification: Class II
Status: Ongoing
Recall initiated: 24 Dec 2019
FDA classified: 10 Feb 2020
Reported: 19 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Infusion Pumps

Timeline

24 Dec 2019	Recall initiated by company
10 Feb 2020	Classified by FDA	+48 days
19 Feb 2020	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082

Where it was distributed

Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.

Nationwide

Questions about this recall

Is US Clinical Programmable Pump recalled?

Yes. Flowonix Medical recalled US Clinical Programmable Pump on 24 Dec 2019. The recall is Class II and its status is Ongoing. Recall number Z-1123-2020.

Why was it recalled?

Which lots are affected?

All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers 10HW4A57 10AX4A06 36ES4A15 36AR4A04 36AR4A06 36AR4A13 36HS4A10 36HS4A54 36JN4A04 36JN4A06 36JN4A07 36JN4A09 36JN4A13 36JN4A14 36JN4A15 36JN4A18 36JN4A23 36JN4A28 36JN4A35 36KN4A11 36KN4A16 36KN4A23 36KN4A27 36KN4A33 36KN4A34 36KN4A41 36HS4A01 10IT4A21 36HS4A14 36HS4A26 36BS4A17 36ES4A28 36ES4A33 36ES4A08 10IT4A16 36FR4A13 36HS4A61 10ET4A07 36HS4A46 10ET4A20 36HS4A25 36HS4A43 10ET4A02

Where was it sold?

Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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