Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump
FDA device recall Z-0272-2023 · posted 2022-11-21 · Open, Classified
Recall details
- Recalling firm
- Smiths Medical ASD Inc.
- Reason for recall
- Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation
- Action taken
- Smiths Medical notified consignees initially via telephone on 10/10/2022 and followed up with a letter via email on 10/11/2022. The letter was titled "URGENT MEDICAL DEVICE CORRECTION" and instructed consignees to locate all affected pumps and ensure all users or potential users of these devices are immediately made aware of this notification and proposed mitigations, complete and return the attached Response Form to fieldactions@smiths-medical.com, and if Smiths Medical does not contact you to schedule the implementation of the software updates, please contact Smiths Medical Technical Assistance. For further inquiries, please contact Smiths Medical using the following information: email: MedfusionFieldCorrections@icumed.com.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 422 devices
- Distribution
- US distribution to states of: Indiana, Texas and Virginia
- Date initiated
- 2022-10-10
- Date posted
- 2022-11-21
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) (K111386) | Smiths Medical MD, Inc. | 2011-08-29 |