Z-0733-2017Class II

Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum...

Name: Z-0733-2017 Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum...
Creator: Cook Inc.
Published: 2016-11-28
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2016-11-28 / Terminated

FDA source

Cook Inc. began a recall of Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central... on 2016-11-28. FDA classified it as Class II and gives the reason as "Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. Potential adverse events that may occur as a...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0733-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-28
Posted: 2016-12-12
Terminated: 2017-09-06
Recalling firm: Cook Incorporated
Product: Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. Potential adverse events that may occur as a result of utilizing needles of incorrect size include delay in treatment, which could be critical in an emergent situation. There have been no reports of illness or injury associated with this issue.
FDA root cause: Mixed-up of materials/components
Action: Cook Medical sent an Urgent - Medical Device Recall letter dated November 23, 2016. to all affected customers. The letter identified the product the problem and the action needed to be taken. Action to be taken: 1. Please review the attached list of affected products and lot numbers that were shipped to your account and quarantine any affected products that remain unused. 2. Immediately collect and return all unused affected products to Cook Medical as soon as possible for credit. 3. Please complete the attached Acknowledgement and Receipt Form and return it to Cook Medical. 4. Please report any adverse event to Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235, Monday through Friday between 7:30 am and 5:00 pm Eastern Standard Time or e-mail at [email protected]. Transmission of this notice: This notice must be passed on to appropriate personnel, including down to the user level, within your organization or to any organization where the potentially affected devices have been transferred. Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235.
Quantity in commerce: 99 units
Distribution: AZ CA DC GA IL LA MN MS NC NV NY OK PA TN TX WI
Product codes and lots: catalog number: C-UDLMY-401J-ABRM-HC-FST Lot 6498570 catalog number: C-UTLMY-501J-ABRM-HC-FST Lot 6501835 Exp date 9/30/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0733-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0733-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-12

Product code FOZ

K033843Class IISpectrum Central Venous Catheter with or without Hydrophilic CoatingCook, Inc. / cleared 2004-08-12

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)