CLASS II Device recall · Reported 28 Mar 2018 · FDA Enforcement Report

Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe recalled

Smiths Medical ASD is recalling Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated, distributed nationwide in the US. The recall was initiated on 13 Nov 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Codes: 4000-0101-50, 4000-0101-51, 4000-0105-50, 4000-0105-51, 4000-0150-78, 4000-0106-00, 4000-0106-01

Quantity recalled16,600 pumps total

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-1134-2018
FDA event ID: 78922
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class II
Status: Terminated
Recall initiated: 13 Nov 2017
FDA classified: 19 Mar 2018
Reported: 28 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Infusion Pumps

Timeline

13 Nov 2017	Recall initiated by company
19 Mar 2018	Classified by FDA	+126 days
28 Mar 2018	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

Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. The inability of a pump to recognize a syringe (i.e. the size of the syringe is unknown to the pump) results in an inability to complete pump programming. Misidentification of a syringe is where the pump misinterprets the syringe size.

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

Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of the syringe infusion pump can be monitored or supervised by a clinician; 5) Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.

Where it was distributed

Worldwide distribution- US nationwide Distribution and to the countries of : Australia, Barbados, Canada, Hong Kong, Indonesia, Jamaica, New Zealand, Philippines, Saudi Arabia, Singapore, South Africa, Trinidad and Tobago, United Arab Emirates, and United Kingdom.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Product Codes: 4000-0101-50, 4000-0101-51, 4000-0105-50, 4000-0105-51, 4000-0150-78, 4000-0106-00, 4000-0106-01

Where was it sold?

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

Other products in this recall event

2 other products · FDA event 78922

This product is part of a recall event; the main page for the event is Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe recalled.

Reported	Class	Recall	Company	Reason	Where
28 Mar 2018	CLASS II	Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe recalled	Smiths Medical ASD	Device Malfunction	Nationwide
28 Mar 2018	CLASS II	Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe recalled	Smiths Medical ASD	Device Malfunction	Nationwide

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