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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy."
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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