Recall Z-1310-2023 ยท FRN Pump, Infusion
Iradimed Corporation
Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
| Date | Mar 30, 2023 (initiated Feb 24, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 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, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Romania, Serbia, Singapore, Singapore, South |
| FDA record | Open on fda.gov |