FDAClass IIOctober 14, 2020

Kit Model #650301023 recall: Sterility Concern

Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any…

Why was Kit Model #650301023 recalled?

Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 5551869, Exp 01/31/2022

Product
Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any…
Recalling firm
Medline Industries Inc
Quantity
20 kits
Distribution
US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
Recall date
October 14, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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