Cook Incorporated Recall 90793
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
Cook Incorporated Recall 90793 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1844-2022 |
| Event ID | 90793 |
| Event 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 |
| Product Type | Devices |
| Distribution | Domestic distribution nationwide. Foreign distribution worldwide. |
| Quantity | 240 US; 108 OUS |
| Recall Reason | 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. |
| Device Classification | 20221005 |
| Device Code Info | 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 |
| Center Classification Date | 20220928 |
| Recall Initiation Date | 20220816 |
| Recalling Firm | Cook Incorporated |
| Initial Notification | Letter |
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