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
- Central Venous Catheter Tray
- Model numbers
- Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, UDI (01)00827002564244(17)261130(10)16288039, Lot Number 16288039, Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, UDI (01)00827002210530(17)260430(10)16029543, Lot Number 16029543, Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260228(10)15681111 +8 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
Cook Spectrum Central Venous Catheter Tray is a medical device used in vascular procedures. Healthcare providers rely on precise labeling to ensure sterility and patient safety.
Why This Is Dangerous
Overstated expiration labeling can misrepresent the product’s sterility window, potentially affecting safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Affects clinical workflows and patient safety; immediate discontinuation reduces risk and preserves sterility.
Practical Guidance
How to identify if yours is affected
- Match reference part numbers: C-UTLMY-701J-ABRM-CUSTOM-0003, -0018, -0042, -0047, -0048
- Check expiration labeling against true shelf life on the device packaging
Where to find product info
Recall notice and Cook Medical customer service channels; lot numbers and expiration labels on tray packaging
What timeline to expect
Refunds or replacements timelines vary; follow Cook’s stated process
If the manufacturer is unresponsive
- Escalate to healthcare facility risk management
- Contact FDA recall enforcement if manufacturer is unresponsive
- Keep documentation of all communications
How to prevent similar issues
- Verify expiration labeling for all sterile devices before use
- Choose shipments with clearly stated shelf life
- Maintain sterile chain of custody and inspect packaging for integrity
Documentation advice
Keep recall notices, purchase documents, batch numbers, photos of labels, and correspondence
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Product Details
Brand: Cook Medical. Product: Spectrum Central Venous Catheter Tray. Reference Part Numbers: C-UTLMY-701J-ABRM-CUSTOM-0003 (Lot 16288039), C-UTLMY-701J-ABRM-CUSTOM-0018 (Lot 16029543), C-UTLMY-701J-ABRM-CUSTOM-0042 (Lot 15681111, 15646726, 15721094, 15620729, 15583884), Orders: G56424, G21053, G34914, G44431, G44432. Quantity: 1,872 units. Distribution: Worldwide. Recall Date: 2026-03-05. Status: ACTIVE.
Reported Incidents
No incidents or injuries are mentioned in the provided recall notice.
Key Facts
- Expiration dates labeling exceeded shelf life
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Safety Guide
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