HIGH

COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number...

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Quick Facts at a Glance

Recall Date
March 5, 2026
Hazard Level
HIGH
Brand
Cook

Hazard Information

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cook Incorporated or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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Full Description

COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Reference Part Number C-PTIS-100-UNS-HC-G-EU, Order Number G57686.. Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.. Classification: Class II. Quantity: 916 units. Distribution: Worldwide distribution.

View Original Recall on FDA - Medical Devices

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Product Classification

Product Details

Brand
Cook
Model Numbers
Reference Part Number C-PTIS-100-HC-G-EU
UDI (01)00827002576858(17)270802(10)16189446
Lot Number 16189446
UDI (01)00827002576858(17)270803(10)16189593
Lot Number 16189593
+9 more
Report Date
April 15, 2026
Recall Status
ACTIVE

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