Cook Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set recalled for incorrect expiration dates
Cook Incorporated discovered that certain lots of the Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set were labeled with expiration dates longer than the actual shelf life of the product. This means some units may have been used past their true expiration date, potentially affecting sterility and safety.
From the FDA notice · Read the official notice ↗ · All Cook recalls
What to do
- If you have this device, check the lot number and reference part number against the FDA recall list
- Do not use the product if it matches a recalled lot number
- Contact Cook Incorporated or your supplier for instructions on replacement or return
- Verify expiration dates on any remaining inventory before use
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 18 products — see all of them.
Details
- Units affected
- 476 units
- Illnesses reported
- None reported
- Manufactured in
- 750 N Daniels Way, Bloomington, IN, United States
- Classification
- Class II
- Recall number
- Z-1785-2026
In the FDA's words
- Description
- Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665. Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Reference Part Number C-TCCSB-500-UNI, UDI (01)00827002321939(17)270803(10)NS16189671, Lot Number NS16189671; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191668, Lot Number 16191668; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270807(10)16195472, Lot Number 16195472; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270807(10)16195467, Lot Number 16195467; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191666, Lot Number 16191666; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191677, Lot Number 16191677; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191661, Lot Number 16191661; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270812(10)16200360, Lot Number 16200360; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270731(10)16185929, Lot Number 16185929; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270904(10)16237917, Lot Number 16237917; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191674, Lot Number 16191674; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191671, Lot Number 16191671; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270806(10)16193388, Lot Number 16193388; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270806(10)16193387, Lot Number 16193387; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191667, Lot Number 16191667; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270807(10)16195473, Lot Number 16195473; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191662, Lot Number 16191662; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191689, Lot Number 16191689; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270807(10)16195468, Lot Number 16195468; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270927(10)16271019, Lot Number 16271019. Distribution: Worldwide distribution. Affected quantity: 476 units
- 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… (this page)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…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