HIGHFDA DEVICE

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."

Official notice
CookHealth & Personal CareMedical DevicesReference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003UDI (01)00827002564244(17)261130(10)16288039Lot Number 16288039

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
March 5, 2026
Status
ACTIVE
Severity
8/10

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

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 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.

  1. Recall announced

    March 5, 2026

  2. Reported by FDA DEVICE

    April 15, 2026

  3. RecallRadar source check

    April 22, 2026

  4. 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

  1. Match reference part numbers: C-UTLMY-701J-ABRM-CUSTOM-0003, -0018, -0042, -0047, -0048
  2. 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

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

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

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

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

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

Related Recalls