Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
Summary
The FDA issued a Class II for Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - S by Iradimed Corporation. Reason: Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part whic.
Details
Source
Device Recall
External ID
Z-1310-2023
Action Date
2023-04-05
Status
Ongoing
Category
device
Product Description
Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
Lot/Code Info: UDI di 10856038001048, Lot Numbers: 21K50N, exp. 11/30/2023; 22A03N, exp. 01/31/2024; 22A59N, exp. 2/29/2024; 22B54N, exp. 2/29/2024; 22D15N, exp. 4/30/2024; 22D28N, exp. 4/30/2024; 22D58N, exp. 4/30/2024; 22I17N, exp. 9/30/2024; 031851, exp. 9/30/2024; 22J46N, exp. 10/31/2024; 032198, exp. 11/30/2024; 22L02N,exp. 12/31/2024; 032822, exp. 1/31/2025
Quantity Affected: 3285 boxes of 50 devices
Reason for Recall
Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the syringe venting function which then can result in occlusion.
Distribution
Worldwide distribution - US Nationwide and the countries of Austria, Canada, Chile, Denmark, Germany, Great Britain, Hong Kong, Indonesia, Italy, Korea, Kuwait, Malaysia, Netherlands, Nicaragua, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Romania, Serbia, Singapore, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-24
Company
Winter Springs, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 119 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Iradimed Corporation has 2 FDA actions in our database, including 1 recall and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Iradimed Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Iradimed Corporation have FDA actions?
Iradimed Corporation has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1310-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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