Cook Medical Spectrum Central Venous Catheter Sets recalled for incorrect expiration dates
Cook Medical Spectrum Central Venous Catheter Sets in certain lots were labeled with expiration dates that go beyond their actual shelf life. This means some catheters may have degraded beyond their labeled date of use. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Cook recalls
What to do
- Check your inventory for the affected lot numbers listed in the FDA notice
- Do not use any catheters from recalled lots after their true expiration date
- Contact Cook Medical or your supplier with your lot numbers for replacement or instructions
- Review the FDA recall notice for the complete list of affected part and lot numbers
Is yours affected?
Compare your label or packaging with the recalled product.
- 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.
- Sold in
- Nationwide
- Made for
- Adults (under 100 years)
This recall covers 18 products — see all of them.
Details
- Units affected
- 5080 units
- Illnesses reported
- None reported
- Manufactured in
- 750 N Daniels Way, Bloomington, IN, United States
- Classification
- Class II
- Recall number
- Z-1788-2026
In the FDA's words
- 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
- Hazard
- Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
18 products in this recall
Cook Medical procedure kits recalled for expiration date errors
Cook Medical is recalling 18 product listings, including catheter, tracheostomy, and central venous kits and trays, because some affected lots were labeled with expiration dates longer than their true shelf life. No injuries have been reported, and the products were distributed worldwide.
The agency lists each product separately. Check every one you might have.
- COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786Z-1775-2026 · 15 units
- COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Numbe…Z-1776-2026 · 49 units
- COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number…Z-1777-2026 · 75 units
- COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order…Z-1778-2026 · 20 units
- COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part N…Z-1779-2026 · 916 units
- COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Par…Z-1780-2026 · 441 units
- COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Nu…Z-1781-2026 · 484 units
- COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073Z-1782-2026 · 95 units
- COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number…Z-1783-2026 · 1872 units
- COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108Z-1784-2026 · 49 units
- Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-5…Z-1785-2026 · 476 units
- COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775Z-1786-2026 · 20 units
- COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4,…Z-1787-2026 · 70 units
- 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… (this page)Z-1788-2026 · 5080 units
- 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…Z-1789-2026 · 2348 units
- COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242Z-1790-2026 · 2 units
- COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH,…Z-1791-2026 · 104 units
- COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-1…Z-1792-2026 · 318 units
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ModerateFDAOct 21, 2026