Home / Recalls / Medical Devices
Medline Industries Inc recalls Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist o
Recalled October 14, 2020 · FDA recall Z-0068-2021 · Medline Industries
Hazard
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities. · FDA Class II
Units
16 kits
Sold at
US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
Description
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Product
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).
Manufacturer(s)
Medline Industries Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →