Medline Industries Inc: Medical Device Recall in 2020 - (Recall #: Z-0061-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class II

Date Initiated: September 14, 2020

Date Posted: October 14, 2020

Recall Number: Z-0061-2021

Event ID: 86503

Reason for Recall:

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

Status: Terminated

Product Quantity: 60 kits

Code Information:

Lot 5574586, Exp 01/31/2023

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated