# FDA recall Z-2203-2020

> **Cook Inc.** · Class II · device recall initiated 2020-04-30.

## Product

Pressure Monitoring Set, C-PMS, G02838

## Reason for recall

The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.

## Distribution

Worldwide distribution including distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Washington DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia

## Key facts

- **Recall number:** Z-2203-2020
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-30
- **Report date:** 2020-06-10
- **Termination date:** 2021-03-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2203-2020

## Citation

> AI Analytics. FDA recall Z-2203-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2203-2020. Source: US FDA. Licensed CC0.

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