The Recall Desk
HighFDA (Devices)·Z-1789-2026·Announced 2026-04-15

Cook Medical Spectrum central venous trays carry overstated expiration dates

Cook Medical is recalling Spectrum Central Venous Trays because affected lots were labeled with expiration dates that exceed the product's true shelf life. 2,348 units are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall where an overstated expiry date can lead to use of a sterile device beyond its validated shelf life, a risk of harm with no injuries reported.

Plain-English summary

Cook Medical is recalling the Spectrum Central Venous Tray across several reference part numbers, including C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD and C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, as listed in the recall notice. The action covers 2,348 units.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life of the product. A tray carrying an overstated expiry can be held and used after the point at which its sterility and performance were validated. The FDA classified the action as Class II.

Distribution was worldwide. The trays are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the reference part numbers and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Cook Medical.

The recalled product

Product
COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, Order Number G44809; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, Order Number G
Manufacturer
Cook Incorporated
Category
Medical Device — Central venous tray
Hazard
Affected units
2,348

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD
  • UDI (01)00827002448094(17)280327(10)16530788
  • Lot Number 16530788
  • UDI (01)00827002448094(17)280401(10)16537255
  • Lot Number 16537255
  • UDI (01)00827002448094(17)280417(10)16562522
  • Lot Number 16562522
  • UDI (01)00827002448094(17)280602(10)16625687
  • Lot Number 16625687
  • C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD
  • UDI (01)00827002448063(17)280416(10)NS16523791X
  • Lot Number NS16523791X
  • UDI (01)00827002448063(17)280514(10)NS16523837X
  • Lot Number NS16523837X
  • UDI (01)00827002448063(17)280603(10)NS16523837XX

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 18 recalled by Cook Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 18 products in this recall →

Related recalls

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Same hazard · expiration date error

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