Recall record at a glance
| Official record | Z-0864-2024 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Ongoing |
| Recalling firm | Smiths Medical ASD Inc. |
| Report date | Feb 7, 2024 |
| Recall initiation date | Dec 19, 2023 |
| Quantity | 60146 pumps |
| Location | Minneapolis, MN, United States |
Official product description
smiths medical Medfusion Model 4000 syringe pump
Why the product was recalled
Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 2. Re-administered Loading Dose (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 3. Incorrect Critical Data Failure Alarm, 4. Interruption of Bolus or Loading Dose Delivery (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 5. Incorrect Total Bolus/Loading Dose Displayed (v1.1.0, v1.1.1, v1.1.2), 6. Volume Limit Before Bolus/Loading Dose Complete (v1.1.2), 7. Drug Library Lower Limit Displayed Incorrectly (v1.6.0, v1.6.1), 8. Depleted Battery Alarm (All versions previous to v1.6.5), 9. Loss of Wireless Connectivity (v1.5.0, v1.5.1, v1.6.0, v1.6.1, v1.6.4), 10. PharmGuard Server Password (v2.3, v2.4, v2.5). Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software installed on your pumps.
Distribution information
US nationwide, Canada, Great Britain, Bermuda, Australia, Germany, Singapore, Saudi Arabia, Lebanon, and Malaysia
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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