Cook Incorporated recalled 441 units of the Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray after identifying expiration dates that exceed true shelf life. The recall covers lots with Reference Part Numbers C-PTISY-100-HC-G-NA, C-PTISY-100-UNL-HC-G-NA and C-PTISY-100-UNS-HC-G-NA distributed worldwide. Healthcare providers must stop use and follow manufacturer 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 is a medical device used in percutaneous tracheostomy procedures to introduce tracheostomy access.
Expired shelf life labeling could compromise sterility or device integrity, posing potential patient risk during procedures.
This recall is not part of a broader industry pattern at this time.
Immediate cessation of use is required; no injuries reported in the notice but potential safety risk during procedures.
Review manufacturer recall notice and FDA enforcement page. Check device packaging for lot number and UDI.
Replacement or refund timelines will be provided by Cook Incorporated.
Keep recall notices, lot numbers, UDI codes, purchase records, and all correspondence with Cook.
Brand: Cook. Product: Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray. Reference Part Numbers: C-PTISY-100-HC-G-NA (Order G57703); C-PTISY-100-UNL-HC-G-NA (Order G57706); C-PTISY-100-UNS-HC-G-NA (Order G57704). Distribution: Worldwide. Recall Date: 2026-03-05. Report Date: 2026-04-15. Quantity: 441 units. Classification: Class II.
No injury or adverse-event data is provided in the recall notice.
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