Cook Incorporated recalls 484 Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Sets due to expiration date labeling that exceeds true shelf life. The recall is active and distributed worldwide. Health care providers must stop use and follow recall instructions.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
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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This device is a percutaneous tracheostomy introducer set used in airway management for patients requiring temporary tracheostomy access.
Expiration labeling that exceeds shelf life could compromise device performance or sterility, potentially affecting patient safety.
This recall is not indicated as part of a broader industry pattern.
If not corrected, expired labeling could lead to uncertainty in device sterility and performance, impacting patient safety and hospital workflows.
UDI codes and lot numbers are typically printed on the packaging and device tray; refer to the recall notice for exact identifiers.
Replacement or remedy timelines vary by lot and hospital stock levels; follow manufacturer guidance.
Keep recall notice, verification logs, communications with Cook and suppliers, and replacement receipts
Cook Medical Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set. Reference Part Numbers C-PTIS-100-FLEX-HC (G32092) and C-PTIS-100-HC (G12115). Quantity: 484 units. Distribution: Worldwide. Recall date: 2026-03-05. Status: Active.
No specific injuries or incidents are reported in the provided data.
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