The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name
FDA device recall Z-0446-2013 · posted 2012-11-28 · Terminated
Recall details
- Recalling firm
- Iradimed Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 719 sets
- Distribution
- Nationwide Distribution including AZ, CA, FL, KY, MD, MA, NJ, NY, PA, and TX.
- Date initiated
- 2012-08-24
- Date posted
- 2012-11-28
- Date terminated
- 2013-07-19
- Location
- Winter Park, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MRIDIUM 3850 MRI PUMP SYSTEM (K050301) | Iradimed Corporation | 2005-03-24 |