Class 2 Device Recall Spectrum Central Venous Catheter Set

• Date Initiated by Firm: March 05, 2026
• Date Posted: April 06, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1788-2026
• Recall Event ID: 98495
• 510(K)Number: K033843 K081113
• Product Classification: Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
• Product: 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.
• Code Information: 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.
• FEI Number: 1820334
• Recalling Firm/ Manufacturer: Cook Incorporated; 750 N Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: Cook Medical Customer Relations Department; 812-457-4500
• Manufacturer Reason for Recall: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
• FDA Determined Cause: Incorrect or no expiration date
• Action: Cook Medical issued an URGENT: MEDICAL DEVICE RECALL to its consignee on 3/5 2026 via courier or email. The notice explained the issue, potential risk to health, and requested the following: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
• Quantity in Commerce: 5080 units
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FOZ