The brand name is MRidium Series 1000 MR Infusion Sets recall
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…
Why was The brand name is MRidium Series 1000 MR Infusion Sets recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
The device Lot Code is LBG001. The "L" indicates facility, Las Piedras Facility. The "B" indicates year manufactured, 2012. The "G" indicates month manufactured, July. The "001" indicates the sequential lot build, restarts at 1 every month.
- Product
- 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…
- Recalling firm
- Iradimed Corporation
- Quantity
- 719 sets
- Distribution
- Nationwide Distribution including AZ, CA, FL, KY, MD, MA, NJ, NY, PA, and TX.
- Recall date
- December 5, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)