Smiths Medical ASD Inc. Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Brand
Smiths Medical ASD Inc.
Lot Codes / Batch Numbers
Model Numbers: 4000-0105-249, 4000-0105-50, 4000-0105-51, 4000-0105-78, 4000-0106-00, 4000-0106-01, and 4000-0106-231. Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Products Sold
Model Numbers: 4000-0105-249, 4000-0105-50, 4000-0105-51, 4000-0105-78, 4000-0106-00, 4000-0106-01, and 4000-0106-231. Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Smiths Medical ASD Inc. is recalling Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1 due to Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026