Smiths Medical Medfusion 4000 Syringe Pump Firmware Recall
Smiths Medical is recalling 626 Medfusion 4000 Syringe Pumps due to a firmware anomaly that may disable battery alarms and interrupt therapy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a firmware defect could interrupt therapy and disable safety alarms, representing a risk of harm to patients even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Smiths Medical ASD Inc. is recalling 626 units of the Medfusion Syringe Pump, Model 4000, due to a firmware anomaly in version 1.7.0. The affected devices are small, lightweight, and portable syringe infusion pumps used for patient care.
The anomaly could potentially result in the loss of primary audible and visual battery alarm functionality and the interruption of therapy. The recall covers devices distributed in Colorado, Maryland, and New York.
Healthcare facilities and users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected. If a device is included in the recall, users should follow the instructions provided by Smiths Medical ASD Inc. for remediation or replacement.
The recalled product
- Product
- Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 626
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial numbers: 2039045
- 2039062
- 2039082
- 2039084
- 2039093
- 2039122
- 2039128
- 2039132
- 2039133
- 2039137
- 2039145
- 2039151
- 2039153
- 2039158
- 2039164
- 2039174
- 2039178
- 2039181
- 2039182
- 2039183
Distribution
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