Home/Recalls/FDA-Z-1788-2026
FDA DevicesClass II

COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDL...

Published: April 15, 2026Recall ID: Z-1788-2026Category: devicesCountry: US

Reason for Recall / Hazard

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Product Description & Identification

COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, Order Number G43986; Reference Part Number C-UDLM-401J-PED-ABRM-HC, Order Number G43984; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, Order Number G24752; Reference Part Number C-UDLM-401J-RSC-ABRM-HC, Order Number G43985; Reference Part Number C-UDLM-501J-ABRM-HC, Order Number G43995; Reference Part Number C-UDLM-501J-PED-ABRM-HC, Order Number G43996; Reference Part Number C-UDLM-501J-RSC-ABRM-HC, Order Number G43997; Reference Part Number C-UDLM-801J-ABRM-HC, Order Number G50817; Reference Part Number C-UQLM-1001J-ABRM-HC-RD, Order Number G51537; Reference Part Number C-UQLM-1001J-RSC-ABRM-HC-RD, Order Number G51539; Reference Part Number C-UTLM-501J-ABRM-HC, Order Number G44005; Reference Part Number C-UTLM-501J-ABRM-HC-CAH, Order Number G24803; Reference Part Number C-UTLM-501J-LSC-ABRM-HC, Order Number G44008; Reference Part Number C-UTLM-501J-PED-ABRM-HC, Order Number G44006; Reference Part Number C-UTLM-501J-RSC-ABRM-HC, Order Number G44007; Reference Part Number C-UTLM-501J-RSC-ABRM-HC-CAH, Order Number G24765; Reference Part Number C-UTLM-701J-ABRM-HC-RD, Order Number G47825; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, Order Number G24809; Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, Order Number G53599; Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, Order Number G47827; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, Order Number G47829; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, Order Number G24810.

Affected Products

COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, Order Number G43986; Reference Part Number C-UDLM-401J-PED-ABRM-HC, Order Number G43984; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, Order Number G24752; Reference Part Number C-UDLM-401J-RSC-ABRM-HC, Order Number G43985; Reference Part Number C-UDLM-501J-ABRM-HC, Order Number G43995; Reference Part Number C-UDLM-501J-PED-ABRM-HC, Order Number G43996; Reference Part Number C-UDLM-501J-RSC-ABRM-HC, Order Number G43997; Reference Part Number C-UDLM-801J-ABRM-HC, Order Number G50817; Reference Part Number C-UQLM-1001J-ABRM-HC-RD, Order Number G51537; Reference Part Number C-UQLM-1001J-RSC-ABRM-HC-RD, Order Number G51539; Reference Part Number C-UTLM-501J-ABRM-HC, Order Number G44005; Reference Part Number C-UTLM-501J-ABRM-HC-CAH, Order Number G24803; Reference Part Number C-UTLM-501J-LSC-ABRM-HC, Order Number G44008; Reference Part Number C-UTLM-501J-PED-ABRM-HC, Order Number G44006; Reference Part Number C-UTLM-501J-RSC-ABRM-HC, Order Number G44007; Reference Part Number C-UTLM-501J-RSC-ABRM-HC-CAH, Order Number G24765; Reference Part Number C-UTLM-701J-ABRM-HC-RD, Order Number G47825; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, Order Number G24809; Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, Order Number G53599; Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, Order Number G47827; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, Order Number G47829; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, Order Number G24810.

Additional Source Details

FieldValue
CityBloomington
StateIN
Event id98495
Address 1750 N Daniels Way
Code infoReference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260424(10)15569919, Lot Number 15569919; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260403(10)15520378, Lot Number 15520378; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260227(10)15487727, Lot Number 15487727; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260227(10)15484947, Lot Number 15484947; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280527(10)16617145, Lot Number 16617145; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280527(10)NS16617419, Lot Number NS16617419; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280527(10)NS16617420, Lot Number NS16617420; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620091, Lot Number NS16620091; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620092, Lot Numbe... [TRUNCATED]
Postal code47404-9120
Report date20260415
Product typeDevices
Product quantity5080 units
Reason for recallProducts from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260305
Initial firm notificationTwo or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date20260406

Overview

  • Recalling FirmCook Incorporated
  • StatusOngoing
  • Risk LevelClass II
  • DistributionWorldwide distribution.
Official Agency Alert

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