HIGH

Cook Medical Spectrum Central Venous Catheter Tray Recalled for Expired Shelf Life Labels (2026)

Cook Medical recalled 1,872 units of Spectrum Central Venous Catheter Trays worldwide due to expiration dates labeling that exceed true shelf life. Healthcare providers should stop using affected lots immediately and follow manufacturer instructions."

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

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

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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

  1. Match reference part numbers: C-UTLMY-701J-ABRM-CUSTOM-0003, -0018, -0042, -0047, -0048
  2. Verify associated lot numbers: 16288039, 16029543, 15681111, 15646726, 15721094, 15620729, 15583884
  3. 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

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

  • 1,872 units recalled
  • Expiration dates labeling exceeded shelf life
  • Lots include: 16288039, 16029543, 15681111, 15646726, 15721094, 15620729, 15583884
  • Global distribution

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPETS
Injury Types
ELECTRICALLACERATIONSUFFOCATIONBURNOTHER

Product Details

Brand
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
+11 more
Report Date
April 15, 2026
Recall Status
ACTIVE

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