# FDA recall Z-1427-2023

> **Cook Incorporated** · Class I · device recall initiated 2023-04-07.

## Product

Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PTIS-100-HC-G-NA-FLEX8.5 (G57692)

## Reason for recall

There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories.  This resulted in an unsecure connection between the device connector and circuit components, cap, or accessories.

## Distribution

Worldwide distribution - US Nationwide.

## Key facts

- **Recall number:** Z-1427-2023
- **Recalling firm:** Cook Incorporated
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-07
- **Report date:** 2023-05-17

- **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-1427-2023

## Citation

> AI Analytics. FDA recall Z-1427-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1427-2023. Source: US FDA. Licensed CC0.

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