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).

Recall Insight

This FDA Devices action (record #Z-0061-2021) was formally reported on October 14, 2020, with the manufacturer initiating the action on September 14, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Medline Industries Inc is listed as the recalling firm, operating out of Northfield, IL. Federal records indicate 60 kits units are affected.

The documented reason for this recall is: Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities. Distribution data in the federal record shows the product reached: US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.