FDA Medical devices recall ·
COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number… recall
- Recall number
- Z-1789-2026
- Date
- (initiated March 5, 2026)
- Company / brand
- Cook Incorporated
750 N Daniels Way, Bloomington, IN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2348 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
Worldwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1789-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.