Recall Z-0446-2013 ยท FRN Pump, Infusion
Iradimed Corporation
The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set. Labeling indicates ~10 ml, Latex-free Infusion Set with Needle-free Port, One injection Port. Device is single use only, do not resterilize, and is available only by prescription. Device made in U.S.A. by Iradimed Corporation located in Winter
| Date | Nov 28, 2012 (initiated Aug 24, 2012) |
| Status | Terminated |
| Reason | Iradimed Corporation is recalling MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001 because a section of the device does not meet specifications. |
| Root cause | Nonconforming Material/Component |
| Action | Iradimed Corporation contacted all affected customers directly by phone, and followed up with an email notification. Customers were instructed to return the product to Iradimed Corporation. For questions regarding this recall call 407-677-8022. |
| Quantity | 719 sets |
| Distribution | Nationwide Distribution including AZ, CA, FL, KY, MD, MA, NJ, NY, PA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050301 | MRIDIUM 3850 MRI PUMP SYSTEM Iradimed Corporation, Mar 24, 2005 |