FDA-Device2023-05-17Class I
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721), C-PTISY-100-HC-G-NA-FLEX8.5 (G57717), C-PTISY-100-HC-G-NA-FLEX7.5 (G57716)
Cook Incorporated
Hazard
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.
Sold states
Worldwide distribution - US Nationwide.
Affected count
25,161 units
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721), C-PTISY-100-HC-G-NA-FLEX8.5 (G57717), C-PTISY-100-HC-G-NA-FLEX7.5 (G57716)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1428-2023Don't want to check this manually?
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