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Mridium mri infusion system - syringe adapter set
Official notice
31 Mar 2023
Last checked
31 Mar 2023
An official Health Canada notice concerns Mridium mri infusion system - syringe adapter set. Finished 1057 sets made with a occluded air pathway will trigger the inlet occlusion alarm of the pump and stop delivery of medication until the inlet occlusion is resolved by replacement of the 1057 IV set. The pump detects the inlet occlusion functions as specified, the occluded air venting pathway is not per specification for the 1057 IV set. This can lead to a hazard situation of a delay of therapy and possible under-dosing which could result in serious adverse health events. Recall start date: February 27, 2023 Published 2023-03-31.
What to do now
Contact the manufacturer if you require additional information.
Recall number
73420
Official notice
2023-03-31
The hazard
The hazard
Finished 1057 sets made with a occluded air pathway will trigger the inlet occlusion alarm of the pump and stop delivery of medication until the inlet occlusion is resolved by replacement of the 1057 IV set. The pump detects the inlet occlusion functions as specified, the occluded air venting pathway is not per specification for the 1057 IV set. This can lead to a hazard situation of a delay of therapy and possible under-dosing which could result in serious adverse health events. Recall start date: February 27, 2023
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Iradimed, Mridium Mri Infusion System - Syringe Adapter Set.
Source & status
Source & status
Source
Tier
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Classification
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Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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