FDAFDA · Food and drugs·Recall number Z-0062-2021
Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - 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).
Published October 14, 2020 · Recall initiated: September 14, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medline Industries Inc
- Distributor
- US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
- Lot
- Lot 5554524, Exp 12/31/2022; second lot with no lot recorded and no exp identified
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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