Cook recalls Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Trays with reference part numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 and others due to unsecure connections that could lead to disconnection during use.
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 specific models of Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Trays because they may not connect securely with 15mm circuit components, risking disconnection during medical procedures. This could lead to complications for patients needing tracheostomy care.
The trays may not make a secure connection with 15mm cap and circuit components, which can cause disconnections during medical procedures. This could lead to complications for patients needing tracheostomy care.
Patients using tracheostomy care equipment with these specific tray models are most at risk. Healthcare providers who use these trays in medical settings may also be affected.
Check for reference part numbers C-PTISYJ-100-HC-G-EU-FLEX8.5, C-PTISYJ-100-HC-G-NA-FLEX7.5, C-PTISYJ-100-HC-G-NA-FLEX8.5, C-PTISY-100-HC-G-NA-FLEX8.5, or C-PTISY-100-HC-G-NA-FLEX7.5. Also look for specific lot numbers and UDI-DI codes listed in the recall notice.
Inspect the tray for loose connections with 15mm circuit components, caps, or accessories. If connections are loose, stop using the tray immediately.
The affected part numbers include C-PTISYJ-100-HC-G-EU-FLEX8.5, C-PTISYJ-100-HC-G-NA-FLEX7.5, C-PTISYJ-100-HC-G-NA-FLEX8.5, C-PTISY-100-HC-G-NA-FLEX8.5, and C-PTISY-100-HC-G-NA-FLEX7.5.
Check the reference part number and lot numbers listed in the recall notice. Affected units have specific UDI-DI codes and lot numbers provided in the recall details.
The recall does not specify a return process, but you should inspect the tray for loose connections and stop using it if connections are insecure.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1428-2023 — Cook Cook Hello, I own a Cook that is covered by recall Z-1428-2023 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.
