CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report

Central Venous Tray Triple Lumen Polyurethane Catheter recalled by Cook

Cook is recalling Central Venous Tray Triple Lumen Polyurethane Catheter, distributed nationwide in the US. The recall was initiated on 31 Jul 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number (Expiration date): 5901462 (30-January-2018)

Quantity recalled50

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0633-2018
FDA event ID: 79050
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 31 Jul 2017
FDA classified: 15 Feb 2018
Reported: 21 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

31 Jul 2017	Recall initiated by company
15 Feb 2018	Classified by FDA	+199 days
21 Feb 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Central venous catheters may not fit over guide wire potentially causing procedure delay.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alabama California Colorado District of Columbia Florida Georgia Iowa Illinois Kentucky Louisiana Maryland Michigan Minnesota Missouri North Carolina New York Ohio Oklahoma Oregon Pennsylvania

Questions about this recall

Why was it recalled?

Central venous catheters may not fit over guide wire potentially causing procedure delay.

Which lots are affected?

Lot Number (Expiration date): 5901462 (30-January-2018)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 79050

Reported	Class	Recall	Company	Reason	Where
21 Feb 2018	CLASS II	Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane recalled	Cook	Device Malfunction	Nationwide
21 Feb 2018	CLASS II	Central Venous Catheter Set Triple Lumen Polyurethane recalled by Cook	Cook	Device Malfunction	Nationwide
21 Feb 2018	CLASS II	Central Venous Catheter Tray Triple Lumen Polyurethane recalled by Cook	Cook	Device Malfunction	Nationwide
21 Feb 2018	CLASS II	Spectrum Central Venous Catheter Tray Minocycline/Rifampin recalled	Cook	Device Malfunction	Nationwide

More recalls from Cook

All 349

Reported	Class	Recall	Company	Reason	Where
13 May 2026Device	CLASS I	Beacon Tip Centimeter Sizing Catheter RPN/GPN recalled	Cook	Device Malfunction	Nationwide
13 May 2026Device	CLASS I	Aurous Centimeter Sizing Catheter RPN recalled by Cook Incorporated	Cook	Device Malfunction	Nationwide
13 May 2026Device	CLASS I	Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-Pig-csc recalled	Cook	Device Malfunction	Nationwide
15 Apr 2026Device	CLASS II	Medical Cook Staged Extubation Set: Reference recalled	Cook	Other	IN
15 Apr 2026Device	CLASS II	Medical Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference recalled	Cook	Other	IN

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide