# FDA recall Z-1362-2022

> **Cook Incorporated** · Class II · device recall initiated 2022-05-25.

## Product

Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

## Reason for recall

The products may contain excess coating material on the outside and/or interior of the needle component.  Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering the bloodstream which may result in pulmonary embolism or ischemia.

## Distribution

US Nationwide.  Brazil, Canada,

## Key facts

- **Recall number:** Z-1362-2022
- **Recalling firm:** Cook Incorporated
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2022-05-25
- **Report date:** 2022-07-20

- **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-1362-2022

## Citation

> AI Analytics. FDA recall Z-1362-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1362-2022. Source: US FDA. Licensed CC0.

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