# FDA recall Z-0063-2021

> **Medline Industries Inc** · Class II · device recall initiated 2020-09-14.

## 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

- **Recall number:** Z-0063-2021
- **Recalling firm:** Medline Industries Inc
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0063-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0063-2021. Source: US FDA. Licensed CC0.

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