FDA-Device2020-10-14Class II
Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).
Medline Industries Inc
Hazard
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Sold states
US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
Affected count
16 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0068-2021Don't want to check this manually?
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