FDA-Device2023-05-17Class I
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PTIS-100-HC-G-NA-FLEX8.5 (G57692)
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
3.053 units
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PTIS-100-HC-G-NA-FLEX8.5 (G57692)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1427-2023More Cook Incorporated recalls
- FDA-Device2026-04-15Cook Medical arterial pressure monitoring trays recalled for incorrect expiration dates
- FDA-Device2026-04-15Cook Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set recalled for incorrect expiration dates
- FDA-Device2026-04-15Cook Medical Strange Bile Duct Stone Exploration Set recalled for incorrect expiration dates
- FDA-Device2026-04-15Cook Medical Wayne Pneumothorax Set recalled for incorrect expiration dates
- FDA-Device2026-04-15Cook Medical Blue Rhino G2 tracheostomy introducer tray recalled for incorrect expiration dates
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