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.
Enforcement
- Recall Number
- Z-1788-2026
- Event ID
- 98495
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cook Incorporated
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- April 15, 2026
- Initiation Date
- March 5, 2026
- Classification Date
- April 6, 2026
- Address
- 750 N Daniels Way, Bloomington, IN, 47404-9120, United States
Description
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.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Reference 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 Number NS16620092; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620093, Lot Number NS16620093; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620094, Lot Number NS16620094; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620414, Lot Number NS16620414; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620415, Lot Number NS16620415; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620416, Lot Number NS16620416; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622160, Lot Number NS16622160; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622161, Lot Number NS16622161; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622162, Lot Number NS16622162; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622163, Lot Number NS16622163; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622164, Lot Number NS16622164; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622165, Lot Number NS16622165; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622166, Lot Number NS16622166; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622167, Lot Number NS16622167; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622168, Lot Number NS16622168; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280602(10)NS16625835, Lot Number NS16625835; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, UDI (01)00827002247543(17)260619(10)NS15668028, Lot Number NS15668028; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, UDI (01)00827002247543(17)260227(10)NS15473245, Lot Number NS15473245; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, UDI (01)00827002439863(17)260213(10)NS15282739, Lot Number NS15282739; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, UDI (01)00827002439863(17)260213(10)NS15282763, Lot Number NS15282763; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, UDI (01)00827002439863(17)260213(10)NS15583873, Lot Number NS15583873; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, UDI (01)00827002439863(17)280714(10)NS16692824, Lot Number NS16692824; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)260314(10)15557442, Lot Number 15557442; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)260314(10)15520367, Lot Number 15520367; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)260220(10)15518160, Lot Number 15518160; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)260327(10)15594051, Lot Number 15594051; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)280426(10)16576182, Lot Number 16576182; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)280527(10)16617146, Lot Number 16617146; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)280529(10)16622169, Lot Number 16622169; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)280612(10)16642446, Lot Number 16642446; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, UDI (01)00827002247529(17)260327(10)NS15583886, Lot Number NS15583886; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, UDI (01)00827002247529(17)260314(10)NS15501647, Lot Number NS15501647; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, UDI (01)00827002247529(17)260220(10)NS15514024, Lot Number NS15514024; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, UDI (01)00827002247529(17)280331(10)NS16534729, Lot Number NS16534729; Reference Part Number C-UDLM-401J-RSC-ABRM-HC, UDI (01)00827002439856(17)280423(10)16572552, Lot Number 16572552; Reference Part Number C-UDLM-501J-ABRM-HC, UDI (01)00827002439955(17)280311(10)16505314, Lot Number 16505314; Reference Part Number C-UDLM-501J-ABRM-HC, UDI (01)00827002439955(17)280412(10)16554636, Lot Number 16554636; Reference Part Number C-UDLM-501J-ABRM-HC, UDI (01)00827002439955(17)280416(10)16559432, Lot Number 16559432; Reference Part Number C-UDLM-501J-ABRM-HC, UDI (01)00827002439955(17)280423(10)16572551, Lot Number 16572551; Reference Part Number C-UDLM-501J-PED-ABRM-HC, UDI (01)00827002439962(17)260619(10)NS15582078, Lot Number NS15582078; Reference Part Number C-UDLM-501J-RSC-ABRM-HC, UDI (01)00827002439979(17)280428(10)NS16577963, Lot Number NS16577963; Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280206(10)NS16454754, Lot Number NS16454754; Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280206(10)NS16454756, Lot Number NS16454756; Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280505(10)NS16587983, Lot Number NS16587983; Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280521(10)NS16612427, Lot Number NS16612427; Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280528(10)NS16620419, Lot Number NS16620419; Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280623(10)NS16657119, Lot Number NS16657119; Reference Part Number C-UQLM-1001J-ABRM-HC-RD, UDI (01)00827002515376(17)260417(10)15478180, Lot Number 15478180; Reference Part Number C-UQLM-1001J-RSC-ABRM-HC-RD, UDI (01)00827002515390(17)280402(10)16539971, Lot Number 16539971; Reference Part Number C-UTLM-501J-ABRM-HC, UDI (01)00827002440050(17)260626(10)15628883, Lot Number 15628883; Reference Part Number C-UTLM-501J-ABRM-HC, UDI (01)00827002440050(17)260130(10)15496521, Lot Number 15496521; Reference Part Number C-UTLM-501J-ABRM-HC-CAH, UDI (01)00827002248038(17)260626(10)NS15660282, Lot Number NS15660282; Reference Part Number C-UTLM-501J-ABRM-HC-CAH, UDI (01)00827002248038(17)260626(10)NS15628880, Lot Number NS15628880; Reference Part Number C-UTLM-501J-ABRM-HC-CAH, UDI (01)00827002248038(17)280505(10)NS16588033, Lot Number NS16588033; Reference Part Number C-UTLM-501J-LSC-ABRM-HC, UDI (01)00827002440081(17)280402(10)16539976, Lot Number 16539976; Reference Part Number C-UTLM-501J-LSC-ABRM-HC, UDI (01)00827002440081(17)280416(10)NS16493943XX, Lot Number NS16493943XX; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260710(10)NS15643882, Lot Number NS15643882; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260626(10)NS15683399, Lot Number NS15683399; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260327(10)NS15559871, Lot Number NS15559871; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260327(10)NS15597521, Lot Number NS15597521; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260213(10)NS15489151, Lot Number NS15489151; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)280303(10)NS16490614, Lot Number NS16490614; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)280304(10)NS16493940, Lot Number NS16493940; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)280417(10)NS16562685, Lot Number NS16562685; Reference Part Number C-UTLM-501J-RSC-ABRM-HC, UDI (01)00827002440074(17)260327(10)15484937, Lot Number 15484937; Reference Part Number C-UTLM-501J-RSC-ABRM-HC-CAH, UDI (01)00827002247659(17)280328(10)NS16532973, Lot Number NS16532973; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)260417(10)15550737, Lot Number 15550737; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)260417(10)15553839, Lot Number 15553839; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)260417(10)15565537, Lot Number 15565537; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)260327(10)15520384, Lot Number 15520384; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)260713(10)15655329, Lot Number 15655329; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280318(10)16514973, Lot Number 16514973; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280331(10)16535286, Lot Number 16535286; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280411(10)16554189, Lot Number 16554189; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280414(10)16556349, Lot Number 16556349; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280430(10)16580721, Lot Number 16580721; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280502(10)16584953, Lot Number 16584953; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280602(10)16625683, Lot Number 16625683; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280602(10)16625826, Lot Number 16625826; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280606(10)16634342, Lot Number 16634342; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280609(10)16636211, Lot Number 16636211; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280609(10)16636220, Lot Number 16636220; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280611(10)16639240, Lot Number 16639240; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, UDI (01)00827002248090(17)280318(10)16514972, Lot Number 16514972; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, UDI (01)00827002248090(17)280328(10)16532975, Lot Number 16532975; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, UDI (01)00827002248090(17)280412(10)16554638, Lot Number 16554638; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, UDI (01)00827002248090(17)280417(10)16562523, Lot Number 16562523; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, UDI (01)00827002248090(17)280429(10)16579251, Lot Number 16579251; Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, UDI (01)00827002535992(17)260410(10)15518162, Lot Number 15518162; Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, UDI (01)00827002535992(17)260822(10)15586027, Lot Number 15586027; Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, UDI (01)00827002478275(17)280401(10)NS16537254, Lot Number NS16537254; Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, UDI (01)00827002478275(17)280501(10)NS16582898, Lot Number NS16582898; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)260403(10)15660266, Lot Number 15660266; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)260403(10)15655331, Lot Number 15655331; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)260403(10)15683408, Lot Number 15683408; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280414(10)16556179, Lot Number 16556179; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280414(10)16556350, Lot Number 16556350; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280602(10)16625673, Lot Number 16625673; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280602(10)16625817, Lot Number 16625817; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280702(10)16678414, Lot Number 16678414; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280702(10)16678420, Lot Number 16678420; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280702(10)16678428, Lot Number 16678428; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280708(10)16683763, Lot Number 16683763; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280708(10)16683788, Lot Number 16683788; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, UDI (01)00827002248106(17)260403(10)15687199, Lot Number 15687199; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, UDI (01)00827002248106(17)280412(10)16554639, Lot Number 16554639; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, UDI (01)00827002248106(17)280415(10)16557470, Lot Number 16557470; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, UDI (01)00827002248106(17)280602(10)16625682, Lot Number 16625682; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, UDI (01)00827002248106(17)280612(10)16642011, Lot Number 16642011.
Worldwide distribution.
5080 units