FDA-Device2026-04-15Class II

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.

Cook Incorporated
Hazard
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Sold states
Worldwide distribution.
Affected count
2348 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1789-2026

Original summary

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

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