| | Class 2 Device Recall Spectrum Central Venous Tray |  |
| Date Initiated by Firm | March 05, 2026 |
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| Date Posted | April 06, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1789-2026 |
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| Recall Event ID |
98495 |
| 510(K)Number | K081113 |
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| Product Classification |
Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
|
| Product | 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-701J-ABRM-HC-IHI-FST-A-RD, Order Number G44809;
Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, Order Number G44806;
Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-IHI-FST-A-RD, Order Number G44807. |
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| Code Information |
C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448001(17)280512(10)NS16597252, Lot Number NS16597252;
C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448001(17)280513(10)NS16600633, Lot Number NS16600633;
C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, UDI (01)00827002448094(17)280327(10)16530788, Lot Number 16530788;
C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, UDI (01)00827002448094(17)280401(10)16537255, Lot Number 16537255;
C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, UDI (01)00827002448094(17)280417(10)16562522, Lot Number 16562522;
C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, UDI (01)00827002448094(17)280602(10)16625687, Lot Number 16625687;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280416(10)NS16523791X, Lot Number NS16523791X;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280514(10)NS16523837X, Lot Number NS16523837X;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280603(10)NS16523837XX, Lot Number NS16523837XX;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280324(10)NS16523838, Lot Number NS16523838;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280324(10)NS16523839, Lot Number NS16523839;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280324(10)NS16523840, Lot Number NS16523840;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588043, Lot Number NS16588043;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588056, Lot Number NS16588056;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588057, Lot Number NS16588057;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588058, Lot Number NS16588058;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588059, Lot Number NS16588059;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588060, Lot Number NS16588060;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588061, Lot Number NS16588061;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588062, Lot Number NS16588062;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280505(10)NS16588063, Lot Number NS16588063;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280507(10)NS16590737, Lot Number NS16590737;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280507(10)NS16590738, Lot Number NS16590738;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280507(10)NS16590739, Lot Number NS16590739;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596195, Lot Number NS16596195;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596196, Lot Number NS16596196;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596197, Lot Number NS16596197;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596198, Lot Number NS16596198;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596199, Lot Number NS16596199;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596200, Lot Number NS16596200;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596201, Lot Number NS16596201;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596202, Lot Number NS16596202;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16596430, Lot Number NS16596430;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597248, Lot Number NS16597248;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597249, Lot Number NS16597249;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597269, Lot Number NS16597269;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597270, Lot Number NS16597270;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597271, Lot Number NS16597271;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597272, Lot Number NS16597272;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597273, Lot Number NS16597273;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597274, Lot Number NS16597274;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597275, Lot Number NS16597275;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597276, Lot Number NS16597276;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280512(10)NS16597277, Lot Number NS16597277;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280513(10)NS16600640, Lot Number NS16600640;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280513(10)NS16600641, Lot Number NS16600641;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280513(10)NS16600642, Lot Number NS16600642;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280513(10)NS16600653, Lot Number NS16600653;
C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, UDI (01)00827002448063(17)280513(10)NS16600654, Lot Number NS16600654;
C-UTLMYJ-701J-RSC-ABRM-HC-IHI-FST-A-RD, UDI (01)00827002448070(17)280602(10)16625668, Lot Number 16625668. |
| FEI Number |
1820334
|
Recalling Firm/
Manufacturer |
Cook Incorporated
750 N Daniels Way
Bloomington IN 47404-9120
|
| For Additional Information Contact | Cook Medical Customer Relations Department
812-457-4500 |
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Manufacturer Reason
for Recall | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
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FDA Determined
Cause 2 | Incorrect or no expiration date |
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| Action | Cook Medical issued an URGENT: MEDICAL DEVICE RECALL to its consignee on 3/5 2026 via courier or email. The notice explained the issue, potential risk to health, and requested the following:
Actions to be Taken by the Customer
1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products.
2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions.
3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com).
4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred.
5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com.
If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235. |
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| Quantity in Commerce | 2348 units |
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| Distribution | Worldwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = FOZ
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