Quick Facts at a Glance
- Recall Date
- March 5, 2026
- Hazard Level
- HIGH
- Brand
- Cook
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- INFANTS, GENERAL, PREGNANT
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-HC-G-EU, UDI (01)00827002576858(17)270802(10)16189446, Lot Number 16189446, UDI (01)00827002576858(17)270803(10)16189593, Lot Number 16189593, UDI (01)00827002576858(17)270725(10)16175956, Lot Number 16175956, UDI (01)00827002576858(17)270725(10)16175957 +6 more
- Sold at
- Multiple Retailers
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
The Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set is a specialty medical device used during percutaneous tracheostomy procedures.
Why This Is Dangerous
Mislabeling expiration dates could mean devices may be past shelf life, potentially affecting sterility or performance.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Immediate use cessation required for affected lots; potential impact on patient safety if used beyond shelf life.
Practical Guidance
How to identify if yours is affected
- Check reference part numbers: C-PTIS-100-HC-G-EU, C-PTIS-100-HC-G-NA, C-PTIS-100-UNL-HC-G-EU, C-PTIS-100-UNS-HC-G-EU.
- Cross-reference UDI and Lot Numbers listed in the recall notice.
- Compare expiration date labeling to true shelf life.
Where to find product info
FDA enforcement page and Cook Medical recall communications.
What timeline to expect
Recall notices provided; replacement or corrective actions communicated by Cook.
If the manufacturer is unresponsive
- Escalate to hospital risk management or patient safety office.
- File a report with the hospital's recall liaison.
How to prevent similar issues
- Verify expiration labeling on all medical devices before use.
- Maintain a system for tracking expiration dates in sterile inventories.
- Request updated labeling or replacements for recalled lots.
Documentation advice
Retain recall notice, document lot numbers, take photos of labeling for records.
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Product Details
Product: Cook Medical Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set. Reference Part Numbers: C-PTIS-100-HC-G-EU (Order G57685), C-PTIS-100-HC-G-NA (Order G57682), C-PTIS-100-UNL-HC-G-EU (Order G57687), C-PTIS-100-UNS-HC-G-EU (Order G57686). UDI data and lot numbers listed in the recall notice. Quantity: 916 units. Distribution: Worldwide.
Reported Incidents
No incident or injury data is provided in the recall notice. No injuries or incidents have been reported.
Key Facts
- Part numbers: C-PTIS-100-HC-G-EU, C-PTIS-100-HC-G-NA, C-PTIS-100-UNL-HC-G-EU, C-PTIS-100-UNS-HC-G-EU
- LD/UDI entries: multiple UDI and lot numbers included
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Safety Guide
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