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U.S. Department of Health and Human Services

Class 2 Device Recall MRIdium MRI Infusion Sets

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 Class 2 Recall
MRIdium MRI Infusion Sets
see related information
Date Posted November 28, 2012
Recall Status1 Terminated on July 19, 2013
Recall Number Z-0446-2013
Recall Event ID 63675
Premarket Notification
510(K) Number
K050301 
Product Classification Pump, Infusion - Product Code FRN
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 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.
Code Information 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.
Recalling Firm/
Manufacturer
Iradimed Corporation
7457 Aloma Ave
Suite 201
Winter Park, Florida 32792-9172
For Additional Information Contact Roger Susi
407-677-8022
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 in Commerce 719 sets
Distribution Nationwide Distribution including AZ, CA, FL, KY, MD, MA, NJ, NY, PA, and TX.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = IRADIMED CORPORATION
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