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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

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Product Detail

Product Description 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 Park, FL 32792. Lot LBG001, Exp 07/2016 The MRidium MRI Infusion Pumps and Infusion Sets are intended for general hospital or clinical use by medical professionals whenever it is required to infuse patients with intra-venous or intra-arterial fluids before, during, or after Magnetic Resonance Imaging (MRI) scans. The device is available for sale only upon the order or a physician or other related licensed medical professional, and not intended for any home use applications.
Recall Number Z-0446-2013
Classification Class II
Code Info 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 Distributed Qty 719 sets
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.

Event Detail

Event Id 63675
Product Type Devices
Status Ongoing
Recalling Firm Iradimed Corporation
City Winter Park
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-24
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including AZ, CA, FL, KY, MD, MA, NJ, NY, PA, and TX.
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