HIGH

Cook Medical Spectrum Central Venous Tray Recalled Over Expired Shelf-Life Labels (2026)

Cook Medical recalled 2,348 Spectrum Central Venous Tray units worldwide due to expiration dates that exceed true shelf life. The recall affects lots labeled with overstated expiration dates. Healthcare providers and patients should stop using the affected devices 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
Multiple Retailers
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

Spectrum Central Venous Trays are used in surgical and critical care settings to gain access to a patient’s central venous system. They are sterile, single-use devices.

Why This Is Dangerous

If expiration dates exceed true shelf life, sterility or device performance could be compromised, potentially impacting patient safety.

Industry Context

This recall is not described as part of a broader industry pattern in the supplied data.

Real-World Impact

This recall creates operational disruption for hospitals and clinics and potential safety concerns for patients during procedures.

Practical Guidance

How to identify if yours is affected

  1. Identify Reference Part Numbers C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD and C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD.
  2. Check lot numbers NS16597252, NS16600633, 16530788, 16537255, 16562522, 16625687.
  3. Review UDI strings listed in the recall.

Where to find product info

Refer to FDA recall page Z-1789-2026 and Cook Medical communications.

What timeline to expect

Refunds or replacements depend on Cook Medical's program; processing may take weeks.

If the manufacturer is unresponsive

  • Escalate to hospital procurement or risk management
  • File a formal complaint with FDA if manufacturer is unresponsive

How to prevent similar issues

  • Verify shelf life before sterilization or use
  • Implement internal recall notification and segregation procedures
  • Maintain up-to-date recalls database for medical devices
  • Cross-check lot numbers with supplier notices

Documentation advice

Document lot numbers, expiration labels, procurement records, and all correspondence with Cook Medical

Product Details

Model numbers and lot details are tied to Reference Part Numbers C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD and C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD. Orders:G44800, G44809, G44806, G44807. Distribution worldwide.

Reported Incidents

No injury counts are provided in the data. If no incidents are reported in the supplied information, this section should reflect that. No injuries or incidents have been reported.

Key Facts

  • 2348 units recalled
  • Lots with expiration dates exceeding shelf life
  • Reference Part Numbers: C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD; C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD; C-…
  • Worldwide distribution
  • Recall status: ACTIVE
  • Recall date: 2026-03-05

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
ELECTRICALPOISONINGLACERATIONOTHER

Product Details

Brand
Model Numbers
C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD
UDI (01)00827002448001(17)280512(10)NS16597252
Lot Number NS16597252
UDI (01)00827002448001(17)280513(10)NS16600633
Lot Number NS16600633
+11 more
Report Date
April 15, 2026
Recall Status
ACTIVE

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