Cook Medical recalled 916 units of the Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set worldwide after discovering expiration dates exceeded true shelf life. The recall affects multiple reference part numbers and order numbers. Healthcare providers should stop using the device immediately and follow Cook’s instructions for recall notification.
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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The Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set is a specialty medical device used during percutaneous tracheostomy procedures.
Mislabeling expiration dates could mean devices may be past shelf life, potentially affecting sterility or performance.
This recall is not part of a broader industry pattern.
Immediate use cessation required for affected lots; potential impact on patient safety if used beyond shelf life.
FDA enforcement page and Cook Medical recall communications.
Recall notices provided; replacement or corrective actions communicated by Cook.
Retain recall notice, document lot numbers, take photos of labeling for records.
Product: Cook Medical Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set. Reference Part Numbers: C-PTIS-100-HC-G-EU (Order G57685), C-PTIS-100-HC-G-NA (Order G57682), C-PTIS-100-UNL-HC-G-EU (Order G57687), C-PTIS-100-UNS-HC-G-EU (Order G57686). UDI data and lot numbers listed in the recall notice. Quantity: 916 units. Distribution: Worldwide.
No incident or injury data is provided in the recall notice. No injuries or incidents have been reported.
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