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Critical recall: Death or serious injury has been reported or is considered likely. Stop using this product now.

Cook Incorporated 2023-05-17 Health critical FDA
Health · FDA · Recall #FDA-Z-1428-2023

Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers… Recall

Issued May 17, 2023 · Cook Incorporated

In May 2023, Cook Incorporated recalled the Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.

Compiled by Maya Ellison, RecallCheckr

What this means for you

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.

What you should do

  1. 1 Stop using Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Cook Incorporated to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Cook Incorporated
Category
Health
Recall date
May 17, 2023
Units affected
Not reported
Sold at
Worldwide distribution - US Nationwide.
Recall number
FDA-Z-1428-2023
Made in
United States
Issuing agency
FDA

In context

  • Cook Incorporated has 12 recalls in our database, including 1 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 903rd Health recall we've logged in 2023.
Read the official FDA notice

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