FDA recall Z-0063-2021

Medline Industries Inc · Class II · device

Product

Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - 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).

Reason for recall

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

Distribution

US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.

Key facts

Status
Terminated
Initiation date
2020-09-14
Report date
2020-10-14
Termination date
2021-04-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0063-2021