Cook Medical Blue Rhino G2-Multi Tracheostomy Introducer Set recalled for incorrect expiration dates
Cook Medical's Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set from certain lots was labeled with expiration dates longer than the actual shelf life of the device. This means some units may have degraded before their printed expiration date, potentially affecting performance when used.
From the FDA notice · Read the official notice ↗ · All Cook recalls
What to do
- Check if you have any of the affected lot numbers listed in the recall notice
- Do not use any units from the recalled lots
- Contact Cook Medical or your supplier for replacement units or further instructions
- Verify the actual expiration date with Cook Medical if you are unsure
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Reference Part Number C-PTIS-100-UNS-HC-G-EU, Order Number G57686.
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 18 products — see all of them.
Details
- Units affected
- 916 units
- Illnesses reported
- None reported
- Manufactured in
- 750 N Daniels Way, Bloomington, IN, United States
- Classification
- Class II
- Recall number
- Z-1779-2026
In the FDA's words
- Description
- COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Reference Part Number C-PTIS-100-UNS-HC-G-EU, Order Number G57686. Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)270802(10)16189446, Lot Number 16189446; Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)270803(10)16189593, Lot Number 16189593; Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)270725(10)16175956, Lot Number 16175956; Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)270725(10)16175957, Lot Number 16175957; Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)270803(10)16189597, Lot Number 16189597; Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)270725(10)16175953, Lot Number 16175953; Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)271001(10)16460934, Lot Number 16460934; Reference Part Number C-PTIS-100-HC-G-NA, UDI (01)00827002576827(17)280318(10)16514949, Lot Number 16514949; Reference Part Number C-PTIS-100-HC-G-NA, UDI (01)00827002576827(17)270725(10)16175948, Lot Number 16175948; Reference Part Number C-PTIS-100-UNL-HC-G-EU, UDI (01)00827002576872(17)260101(10)15151627, Lot Number 15151627; Reference Part Number C-PTIS-100-UNL-HC-G-EU, UDI (01)00827002576872(17)270627(10)16131781, Lot Number 16131781; Reference Part Number C-PTIS-100-UNL-HC-G-EU, UDI (01)00827002576872(17)280218(10)16471138, Lot Number 16471138; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)270725(10)16175951, Lot Number 16175951; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)270725(10)16175949, Lot Number 16175949; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)270724(10)16174015, Lot Number 16174015; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)270725(10)16175955, Lot Number 16175955; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)270724(10)16174023, Lot Number 16174023; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)270801(10)16187746, Lot Number 16187746; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)260327(10)15548776, Lot Number 15548776; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)280121(10)16429827, Lot Number 16429827. Distribution: Worldwide distribution. Affected quantity: 916 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… (this page)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…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
More from Cook
See all- Cook Williams Cystoscopic Injection Needles recalled for faulty Luer lock adapter
ModerateFDAOct 21, 2026