FDAClass IIMarch 28, 2018

Medfusion Syringe Pump 3010 Series The Medfusion¿ recall

Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring…

Why was Medfusion Syringe Pump 3010 Series The Medfusion¿ recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Codes 3010, 3010A with Model No. M03055, M02396, M02315, M02385, M02636, M02780, M02890, M03075, M03245, M03335, M03592, M03599, M03727, M03729, M03817, M03887, M04406, M04568, M04778, M04870, M05494, M05587, M05762, M05766, M05767, M05768, M05849, M06244, M07153, M07159, M07335, M07361, M07443, M07460, M08153, M08157, M08168, M08735, M08736, M08820, M08853, M08871, M08878, M09038, M09057, M09992, M10227, M10229, M10263, M10270, M10325, M10342, M10347, M10353, M10366, M10589, M10879, M10890, M10896, M10900, M11875, M11877, M11898, M11900, M11918, M11919

Product
Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring…
Recalling firm
Smiths Medical ASD Inc.
Quantity
16,600 pumps total
Distribution
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.
Recall date
March 28, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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