Class II

Medical Device Recall: COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.

Cook Incorporated · March 5, 2026

Reason for Recall

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Distribution

Worldwide distribution.

Quantity Affected

484 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1781-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.