Recalls / —
—#182138
Product
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
- FDA product code
- FRN — Pump, Infusion
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K040899, K111386
- Affected lot / code info
- 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
Why it was recalled
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Root cause (FDA determination)
Software design
Action the firm took
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.
Recalling firm
- Firm
- Smiths Medical ASD Inc.
- Address
- 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690
Distribution
- 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
Timeline
- Recall initiated
- 2020-06-26
- Posted by FDA
- 2020-08-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #182138. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.