| Class 2 Device Recall MRIdium MRI Infusion Sets | |
Date Initiated by Firm | August 24, 2012 |
Date Posted | November 28, 2012 |
Recall Status1 |
Terminated 3 on July 19, 2013 |
Recall Number | Z-0446-2013 |
Recall Event ID |
63675 |
510(K)Number | K050301 |
Product Classification |
Pump, infusion - Product Code FRN
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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 FL 32792-9172
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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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = FRN
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