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Recall Observatory FDA recall evidence

Device product

Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.

Z-2735-2020

June 26, 2020

Class I

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 85912
Status
Ongoing
Classification
Class I
Quantity
17019 units
Official record key
device-enforcement:Z-2735-2020

Official wording

Reason: Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

Code information: Model Numbers: 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82. Software Version V6.0

Distribution pattern: Worldwide distribution - United Arab Emirates, United States, Afghanistan, Albania, Australia, Belgium, Bermuda, Canada, China, Germany, Denmark, Great Britain, Hong Kong, Indonesia, Ireland, India, Korea, Kuwait, Lebanon, Mexico, Malaysia, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Saudi Arabia, Trinidad and Tobago

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.