Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
FDA device recall Z-1310-2023 · posted 2023-03-30 · Open, Classified
Recall details
- Recalling firm
- Iradimed Corporation
- Reason for recall
- Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the syringe venting function which then can result in occlusion.
- Action taken
- Iradimed Corporation issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/24/2023 by certified mail. The notice explained the issue and the risk and provided updated instructions for use to mitigate the potential risk of inlet occlusion. For further information concerning this issue or have any questions, please contact Iradimed support via email at SyringeAdapterRecall@Iradimed.com or via telephone at 407-677-8022.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 3285 boxes of 50 devices
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Canada, Chile, Denmark, Germany, Great Britain, Hong Kong, Indonesia, Italy, Korea, Kuwait, Malaysia, Netherlands, Nicaragua, Oman,
- Date initiated
- 2023-02-24
- Date posted
- 2023-03-30
- Location
- Winter Springs, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MRidium 3860+ MRI infusion Pump/ Monitoring System (K143369) | Iradimed Corporation | 2016-12-15 |
| MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM (K090087) | Iradimed Corporation | 2009-04-07 |
| MRIDIUM 3850 MRI PUMP SYSTEM (K050301) | Iradimed Corporation | 2005-03-24 |