CLASS II Device recall · Reported 7 Feb 2018 · FDA Enforcement Report

Graseby 3300 Pump and Graseby 3000 Series Pump Accessories recalled

Smiths Medical ASD is recalling Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. The recall was initiated on 24 Aug 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: 0128-0001, 0128-0025, 0128-0135, 0128-0136, and 0128-0451 Lot/Serial #'s: 1074,8305,8718, 11325, 11540, 16230, 32982, 34076, 42678, 52734, 55337, 60959, 60965, 64104, 67638, 68079, 69199, 72740, 90734, 100817, 12001289, 12001409, 12001557, 12001612, 12008230, 004325, 008303, 012348, 018148, 032159, 041927, 048278, 054171, and 069850

Quantity recalled77

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-0497-2018
FDA event ID: 78943
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class II
Status: Terminated
Recall initiated: 24 Aug 2017
FDA classified: 1 Feb 2018
Reported: 7 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Infusion Pumps

Timeline

24 Aug 2017	Recall initiated by company
1 Feb 2018	Classified by FDA	+161 days
7 Feb 2018	Published in enforcement report	+6 days

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

Reason for recall

In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key.

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

Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion

Where it was distributed

Worldwide Distribution to the countries of : Australia, Canada, Germany, France, Great Britain, Hong Kong, and Ireland

Questions about this recall

Why was it recalled?

In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key.

Which lots are affected?

Model: 0128-0001, 0128-0025, 0128-0135, 0128-0136, and 0128-0451 Lot/Serial #'s: 1074,8305,8718, 11325, 11540, 16230, 32982, 34076, 42678, 52734, 55337, 60959, 60965, 64104, 67638, 68079, 69199, 72740, 90734, 100817, 12001289, 12001409, 12001557, 12001612, 12008230, 004325, 008303, 012348, 018148, 032159, 041927, 048278, 054171, and 069850

Where was it sold?

Worldwide Distribution to the countries of : Australia, Canada, Germany, France, Great Britain, Hong Kong, and Ireland

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.

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9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
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