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
- Cricothyrotomy Catheter Set
- Model numbers
- Reference Part Number C-TCCSB-500-UNI, UDI (01)00827002321939(17)270803(10)NS16189671, Lot Number NS16189671, Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191668, Lot Number 16191668, UDI (01)00827002476653(17)270807(10)16195472, Lot Number 16195472 +7 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
The Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set is used to establish a temporary airway in emergency medical situations when conventional airway access is not possible.
Why This Is Dangerous
Expired labeling may misrepresent shelf life, potentially compromising device integrity and effectiveness during urgent procedures.
Industry Context
This recall is not described as part of a broader pattern in the provided data.
Real-World Impact
Immediate cessation of use is required. Hospitals and clinics must verify lot numbers and halt use of affected units; replacements or refunds will follow the manufacturer’s process.
Practical Guidance
How to identify if yours is affected
- Check reference part numbers: C-TCCSB-500-UNI and C-TCCSB-500-UNI-01
- Verify UDI entries for each part if available
Where to find product info
Manufacturer packaging and labeling show part numbers and lot numbers
What timeline to expect
Recall process timelines vary; expect several weeks for replacements or refunds
If the manufacturer is unresponsive
- Escalate to FDA recall contact
- Document all communications with Cook Incorporated and healthcare facility leadership
How to prevent similar issues
- Implement tighter internal lot verification before distribution
- Review expiration labeling controls
- Source emergency devices only from authorized distributors with traceability
Documentation advice
Maintain recall notices, batch records, and correspondence with Cook Incorporated
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Product Details
Brand: Cook Incorporated. Product: Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set. Reference Part Numbers: C-TCCSB-500-UNI (Order G32193) and C-TCCSB-500-UNI-01 (Order G47665). Lot numbers include NS16189671 and 16191666, 16191661, 16191677, 16191668, 16191666, 16191677, 16195472, 16195467, 16191666. UDI entries provided for each reference. Quantity: 476 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
- 476 total units recalled
- Reference Part Numbers: C-TCCSB-500-UNI and C-TCCSB-500-UNI-01
- Expiration dates mislabeled vs true shelf life
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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