Moderate riskFDA DeviceClass II

Cook Medical Spectrum Central Venous Tray recalled for inaccurate expiration dates

Cook Medical Spectrum Central Venous Trays from certain lots were labeled with expiration dates longer than the products' actual shelf life. This means some trays marked as safe to use may have degraded beyond their true usable period. Approximately 2,348 units are affected across multiple lot numbers.

From the FDA notice · Read the official notice ↗ · All Cook recalls

What to do

  1. If you use or store Cook Medical Spectrum Central Venous Trays, check the lot number on your trays against the FDA recall list.
  2. Do not use affected trays beyond their true expiration date, which may be earlier than the label states.
  3. Contact Cook Medical or your supplier for verified expiration information or replacement trays.
  4. Report any issues with affected trays to the FDA's MedWatch program.

Is yours affected?

Compare your label or packaging with 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 G44806; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-IHI-FST-A-RD, Order Number G44807.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 18 products — see all of them.

Details

Units affected
2348 units
Illnesses reported
None reported
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Classification
Class II
Recall number
Z-1789-2026

In the FDA's words

Description
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 G44806; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-IHI-FST-A-RD, Order Number G44807. Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448001(17)280512(10)NS16597252, Lot Number NS16597252; C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, 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; C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, UDI (01)00827002448094(17)280401(10)16537255, Lot Number 16537255; C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, UDI (01)00827002448094(17)280417(10)16562522, Lot Number 16562522; C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, 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; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280514(10)NS16523837X, Lot Number NS16523837X; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280603(10)NS16523837XX, Lot Number NS16523837XX; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280324(10)NS16523838, Lot Number NS16523838; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280324(10)NS16523839, Lot Number NS16523839; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280324(10)NS16523840, Lot Number NS16523840; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588043, Lot Number NS16588043; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588056, Lot Number NS16588056; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588057, Lot Number NS16588057; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588058, Lot Number NS16588058; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588059, Lot Number NS16588059; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588060, Lot Number NS16588060; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588061, Lot Number NS16588061; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588062, Lot Number NS16588062; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588063, Lot Number NS16588063; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280507(10)NS16590737, Lot Number NS16590737; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280507(10)NS16590738, Lot Number NS16590738; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280507(10)NS16590739, Lot Number NS16590739; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596195, Lot Number NS16596195; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596196, Lot Number NS16596196; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596197, Lot Number NS16596197; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596198, Lot Number NS16596198; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596199, Lot Number NS16596199; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596200, Lot Number NS16596200; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596201, Lot Number NS16596201; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596202, Lot Number NS16596202; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596430, Lot Number NS16596430; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597248, Lot Number NS16597248; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597249, Lot Number NS16597249; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597269, Lot Number NS16597269; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597270, Lot Number NS16597270; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597271, Lot Number NS16597271; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597272, Lot Number NS16597272; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597273, Lot Number NS16597273; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597274, Lot Number NS16597274; C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597275, Lot Number N
Hazard
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

18 products in this recall

Cook Medical procedure kits recalled for expiration date errors

Cook Medical is recalling 18 product listings, including catheter, tracheostomy, and central venous kits and trays, because some affected lots were labeled with expiration dates longer than their true shelf life. No injuries have been reported, and the products were distributed worldwide.

The agency lists each product separately. Check every one you might have.

More from Cook

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Related topics

Expiration date errorMedical devicesSold nationwideMore from FDA Device