Product Wiki · Recalls · U.S. FDA — Device Enforcement

The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR… — recall Z-0446-2013

U.S. FDA — Device Enforcement · United States · 2012-08-24 · Class II

As described by U.S. FDA — Device Enforcement: 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, a

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0446-2013
Date of alert
2012-08-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Iradimed Corporation
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide Distribution including AZ, CA, FL, KY, MD, MA, NJ, NY, PA, and TX.
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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