Medline Industries product recalled over sterility concerns

Recall date

September 14, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Medline Industries Inc recalls Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology…

Recall number

Z-0061-2021

FDA classification

Class II

Brand / firm

Medline Industries Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Kit Model #65021652, MTO Left Heart Kit United Reg Health - 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).