Medfusion 3500 Syringe Infusion Pump with PharmGuard… recallZ-0768-2007 · Smiths Medical MD, Inc. · initiated Feb 3, 2007
Terminated All recalls posted in April 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical MD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Software anomaly that causes the pump to experience a sudden and unexpected failure. This anomaly occurs during the pump's startup sequence when the pump's Preventative Maintenance Alarm goes off, preventing the pump from completing its power up routine. Lock-up occurs and the pump will not function.
FDA root cause category: Other
What the company is doing
Consignees were initially notified of the recall via a Customer Information Bulletin which was sent via electronic mail 2/3/07 and confimed with a telephone conversation. A Product Recall Notification and a Product Recall Bulletin will be sent to all consignees via the mail on 2/16/07.
Recall details
- Recall number
- Z-0768-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 3, 2007
- Posted by the FDA
- Apr 26, 2007
- Recalling firm
- Smiths Medical MD, Inc.
- Quantity
- 23,519
- Product code
- FRN
- FDA submissions
- K982640
- Distribution
- Nationwide, Canada, and Italy.
Product description
Medfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4. Medex, 4350 Green Parkway, Suite 200. Duluth, GA 30096
Code information (models, lots, serial numbers)
Model 3500 pump with 4.1.4 or 4.1.3 software.
Other devices under the same FDA submission
1 device cleared under K982640 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Medfusion 3000CALIcu Medical, Inc. · Pump, infusion1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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