Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-...
FDA Device Recall #Z-1844-2022 — Class II — August 16, 2022
Recall Summary
| Recall Number | Z-1844-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 16, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cook Incorporated |
| Location | Bloomington, IN |
| Product Type | Devices |
| Quantity | 240 US; 108 OUS |
Product Description
Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0-50-ST G02464 C-CTU14.0-30-ST G02898
Reason for Recall
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Distribution Pattern
Domestic distribution nationwide. Foreign distribution worldwide.
Lot / Code Information
CTU14.0-30-ST G02278 UDI-DI: 00827002022782 Lots/Expiration Date: 14806993 22-06-2025 14806994 22-06-2025 14806997 22-06-2025 14807003 22-06-2025 14809136 23-06-2025 14809138 23-06-2025 14809140 23-06-2025 14809141 23-06-2025 14811461 24-06-2025 14823426 01-07-2025 14823427 01-07-2025 14823428 01-07-2025 14823429 01-07-2025 14826334 05-07-2025 14826335 05-07-2025 14826337 05-07-2025 14826338 05-07-2025 14831013 07-07-2025 14831014 07-07-2025 14832846 08-07-2025 14833913 08-07-2025 14834825 11-07-2025 14835074 11-07-2025 14835079 11-07-2025 14835400 11-07-2025 14835401 11-07-2025 14836968 12-07-2025 14836973 12-07-2025 14836974 12-07-2025 14836975 12-07-2025 14841346 14-07-2025 14844979 18-07-2025 14844980 18-07-2025 14844981 18-07-2025 14844983 18-07-2025 14844984 18-07-2025 14847734 19-07-2025 14847738 19-07-2025 NS14809137 23-06-2025 NS14832847 08-07-2025 CTU14.0-40-ST G02327 UDI-DI: 00827002023277 Lots/Expiration Date: 14811457 24-06-2025 14811459 24-06-2025 14811460 24-06-2025 14821325 30-06-2025 14821326 30-06-2025 14826333 05-07-2025 14831010 07-07-2025 14832848 08-07-2025 14835078 11-07-2025 14847740 19-07-2025 NS14818298 29-06-2025 CTU14.0-30 G02791 UDI-DI: 00827002027916 Lots/Expiration Dates: 14816266 28-06-2025 14816268 28-06-2025 14816269 28-06-2025 14816273 28-06-2025 14834821 11-07-2025 14835076 11-07-2025 14835077 11-07-2025 14841348 14-07-2025 14841352 14-07-2025 14847735 19-07-2025 NS14816264 28-06-2025 NS14816265 28-06-2025 NS14831012 07-07-2025 NS14851689 21-07-2025 CTU14.0-50-ST G02464 UDI-DI: 00827002024649 Lots/Expiration Date: 14816271 28-06-2025 14831009 07-07-2025 NS14813459 27-06-2025 NS14826331 05-07-2025 NS14826336 05-07-2025 NS14841345 14-07-2025 C-CTU14.0-30-ST G02898 UDI-DI: 00827002028982 Lots/Expiration Date: 14826332 05-07-2025 NS14816270 28-06-2025
Other Recalls from Cook Incorporated
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0995-2026 | Class II | R¿sch-Uchida Transjugular Liver Access Sets, Re... | Nov 26, 2025 |
| Z-0993-2026 | Class II | Flexor Check-Flo Introducers and Sets, Referenc... | Nov 26, 2025 |
| Z-0994-2026 | Class II | Ring Transjugular Intrahepatic Access Sets, Ref... | Nov 26, 2025 |
| Z-1902-2025 | Class I | Beacon Tip 5.0 Fr Angiographic catheters are de... | May 15, 2025 |
| Z-1786-2025 | Class II | Check=Flo Performer Introducer, 10.0Fr, Referen... | Apr 17, 2025 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.