Z-0631-2018Class II

Central Venous Catheter Tray Triple Lumen Polyurethane, Catalog Identifier: C-UTLMYJ-501J

Name: Z-0631-2018 Central Venous Catheter Tray Triple Lumen Polyurethane, Catalog Identifier: C-UTLMYJ-501J
Creator: Cook Inc.
Published: 2017-07-31
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2017-07-31 / Terminated / root cause: manufacturing process

FDA source

Cook Inc. began a recall of Central Venous Catheter Tray Triple Lumen Polyurethane, Catalog Identifier: C-UTLMYJ-501J Product Usage: The central venous catheter is designed for treatment... on 2017-07-31. FDA classified it as Class II and gives the reason as "Central venous catheters may not fit over guide wire potentially causing procedure delay". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0631-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-31
Posted: 2018-02-15
Terminated: 2019-05-08
Recalling firm: Cook Incorporated
Product: Central Venous Catheter Tray Triple Lumen Polyurethane, Catalog Identifier: C-UTLMYJ-501J Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Central venous catheters may not fit over guide wire potentially causing procedure delay.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Cook sent an Urgent Medical Device Recall dated July 31, 2017 to affected customers. The letter identified the affected product problem and actions to be taken. The letter instructed customers to (1) Examine inventory immediately to determine if you have affected products and quarantine affected products. (2) Return the affected products to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. (3) Even if you do not have affected products on hand, you must still complete the Acknowledgement and Receipt Form and send it via fax (812.339.7316) or email ([email protected]). (4) Complete and return the Acknowledgement and Receipt Form attached to this letter within 30 days. (5) Report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern time), or by email via [email protected].
Quantity in commerce: 25
Distribution: Worldwide distribution - US Nationwide in the states of: AL, CA, CO, FL, GA, IA, IL, KY, LA, MD, MI, MN, MO, NC, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI; the District of Columbia and the countries of Belgium, India Italy, Spain, and United Kingdom.
Product codes and lots: Lot Number (Expiration date): 5919800 (30-May-2018)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0631-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0630-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-15
Z-0631-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-15
Z-0632-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-15
Z-0633-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-15
Z-0634-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-15

Product code FOZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)