Quick Facts at a Glance
- Recall Date
- March 5, 2026
- Hazard Level
- HIGH
- Brand
- Cook
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Cook
- Product type
- Percutaneous Tracheostomy Introducer Set
- Model numbers
- Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270812(10)NS16200246, Lot Number NS16200246, UDI (01)00827002320925(17)270803(10)NS16189601, Lot Number NS16189601, UDI (01)00827002320925(17)270827(10)NS16226797, Lot Number NS16226797, UDI (01)00827002320925(17)270812(10)NS16200247 +6 more
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 5, 2026
Reported by FDA DEVICE
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cook Incorporated or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
This device is a percutaneous tracheostomy introducer set used in airway management for patients requiring temporary tracheostomy access.
Why This Is Dangerous
Expiration labeling that exceeds shelf life could compromise device performance or sterility, potentially affecting patient safety.
Industry Context
This recall is not indicated as part of a broader industry pattern.
Real-World Impact
If not corrected, expired labeling could lead to uncertainty in device sterility and performance, impacting patient safety and hospital workflows.
Practical Guidance
How to identify if yours is affected
- Check reference part numbers: C-PTIS-100-FLEX-HC and C-PTIS-100-HC.
- Cross-check UDI codes listed in the recall.
Where to find product info
UDI codes and lot numbers are typically printed on the packaging and device tray; refer to the recall notice for exact identifiers.
What timeline to expect
Replacement or remedy timelines vary by lot and hospital stock levels; follow manufacturer guidance.
If the manufacturer is unresponsive
- Escalate to hospital compliance officer
- Document all communications with supplier
- Contact FDA/CPQ for guidance if needed
How to prevent similar issues
- Implement expiration-date verification protocols for sterile medical devices
- Train staff on recall response procedures
- Maintain an inventory system that flags expiring lots before shelf life ends
Documentation advice
Keep recall notice, verification logs, communications with Cook and suppliers, and replacement receipts
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Product Details
Cook Medical Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set. Reference Part Numbers C-PTIS-100-FLEX-HC (G32092) and C-PTIS-100-HC (G12115). Quantity: 484 units. Distribution: Worldwide. Recall date: 2026-03-05. Status: Active.
Reported Incidents
No specific injuries or incidents are reported in the provided data.
Key Facts
- Lots with expiration dates exceeding shelf life
- Class II recall
- Active status as of April 15, 2026
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Safety Guide
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