Z-1789-2026Class II

COOK MEDICAL Spectrum Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order...

Name: Z-1789-2026 COOK MEDICAL Spectrum Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order...
Creator: Cook Incorporated
Published: 2026-03-05
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2026-03-05 / Open, Classified / root cause: labeling and UDI

FDA source

Cook Incorporated began a recall of COOK MEDICAL Spectrum Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference Part Number... on 2026-03-05. FDA classified it as Class II and gives the reason as "Products from the affected device lots were labeled with expiration dates that exceed the true shelf life". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1789-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-05
Posted: 2026-04-06
Recalling firm: Cook Incorporated
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.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
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 ([email protected]). 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: [email protected]. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
Quantity in commerce: 2348 units
Distribution: Worldwide distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1789-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1775-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-06
Z-1776-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-06
Z-1777-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-06
Z-1778-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-06
Z-1779-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-06
Z-1780-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-06
Z-1781-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-06
Z-1782-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-06
Z-1783-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-06
Z-1784-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-06
Z-1785-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-06
Z-1786-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-06
Z-1787-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-06
Z-1788-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-06
Z-1789-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-06
Z-1790-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-06
Z-1791-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-06
Z-1792-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-15	2026-04-06

Product code FOZ

K081113Class IICook and Cook Spectrum Central Venous CathetersCook, Inc. / cleared 2008-07-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)