CLASS II ONGOING Device recall · Reported 5 Oct 2022 · FDA Enforcement Report
Vinyl Connecting Tube, Connecting Tube Reference recalled
Cook is recalling Vinyl Connecting Tube, Connecting Tube Reference, distributed nationwide in the US. The recall was initiated on 16 Aug 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1844-2022
- FDA event ID
- 90793
- Recalling firm
- Cook, Bloomington, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Aug 2022
- FDA classified
- 28 Sep 2022
- Reported
- 5 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 16 Aug 2022 | Recall initiated by company | |
| 28 Sep 2022 | Classified by FDA | +43 days |
| 5 Oct 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Domestic distribution nationwide. Foreign distribution worldwide.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Domestic distribution nationwide. Foreign distribution worldwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
23 other products · FDA event 90793This product is part of a recall event; the main page for the event is Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference recalled.
More recalls from Cook
All 349| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Beacon Tip Centimeter Sizing Catheter RPN/GPN recalled | Cook | Device Malfunction | Nationwide |
| Device | CLASS I | Aurous Centimeter Sizing Catheter RPN recalled by Cook Incorporated | Cook | Device Malfunction | Nationwide |
| Device | CLASS I | Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-Pig-csc recalled | Cook | Device Malfunction | Nationwide |
| Device | CLASS II | Medical Cook Staged Extubation Set: Reference recalled | Cook | Other | IN |
| Device | CLASS II | Medical Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference recalled | Cook | Other | IN |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |