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Open, Classified

Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1

FDA Recall Z-2734-2020 · Posted 2020-08-06

Recalling FirmSmiths Medical ASD Inc.
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2020-06-26
Product Quantity35616 units

Reason for Recall

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

Firm Action

Consignees are being contacted via direct mailing and email. Consignees are asked to review and complete the Recall Response form indicating understanding of notification. Distributors are asked to forward the notification to parties to whom product has been distributed. Smiths Medical will send out 2 additional notifications by email. Phone calls will be made to non-responders.

Root Cause

Software design

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111386MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)Smiths Medical MD, Inc. · 2011-08-29K040899MEDEX 3000 SERIES MR SYRINGE INFUSION PUMPMedex, Inc. · 2004-04-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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