Cook recalls Blue Rhino G2 tracheostomy sets with unsecure connections that may cause injury during use. Affected models include EU and NA versions with specific part numbers and lot numbers.
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.
Cook is recalling Blue Rhino G2 tracheostomy introducer sets that have unsecure connections between the device and circuit components. This could lead to injury if the connection fails during medical use.
The tracheostomy sets have a connection that doesn't securely attach to 15mm circuit components, caps, or accessories. This can cause the connection to become loose during use, potentially leading to injury if the device disconnects unexpectedly.
Healthcare professionals using the Blue Rhino G2 tracheostomy sets for medical procedures are most at risk. Patients receiving these devices may also be affected if the connection fails.
Check for the Blue Rhino G2 tracheostomy introducer sets with part numbers C-PTIS-100-HC-G-EU-FLEX7.5, C-PTIS-100-HC-G-EU-FLEX8.5, C-PTIS-100-HC-G-NA-FLEX7.5, or C-PTIS-100-HC-G-NA-FLEX8.5. The product includes specific lot numbers and UDI-DI codes listed in the recall notice.
Review the product's part numbers and lot numbers to confirm if it's affected by this recall.
Reach out to Cook Incorporated directly for assistance with the recall process.
The recall is due to unsecure connections between the tracheostomy set and 15mm circuit components, which could lead to injury if the connection fails during medical use.
Affected models include Blue Rhino G2 tracheostomy sets with part numbers C-PTIS-100-HC-G-EU-FLEX7.5, C-PTIS-100-HC-G-EU-FLEX8.5, C-PTIS-100-HC-G-NA-FLEX7.5, and C-PTIS-100-HC-G-NA-FLEX8.5, along with specific lot numbers and UDI-DI codes.
The recall does not require immediate discontinuation; however, healthcare professionals should verify if their product is affected and contact Cook for guidance.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1427-2023 — Cook Cook Hello, I own a Cook that is covered by recall Z-1427-2023 from Cook. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
