Reported Aug 14, 2013 · Terminated
MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump…
Iradimed Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Iradimed Corporation · 7457 Aloma Ave · Winter Park, FL · 32792-9172
Is this the product you have?
- MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during or after magnetic Resonance imagining (MRI) scans.
- Lot codes and dates
- Part number 1145 Lots
4501451045384587459646754690470547384748496049705001506551046164522152405349536155175737576458816006615161706180625264706583680668816984and 7213
- Part number 1145 Lots
- Amount recalled
- 176 individuals kits
Where it was sold
Why it was recalled
Stop using this product now
The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup. This can result in a risk of over-infusion or under-infusion if the infusion is started with this rate value.
Using this product could cause serious injury, illness or death — stop using it now.
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