CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report
Central Venous Catheter Tray Triple Lumen Polyurethane recalled by Cook
Cook is recalling Central Venous Catheter Tray Triple Lumen Polyurethane, 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
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-0631-2018
- 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
- 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 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
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 AlabamaCaliforniaColoradoDistrict of ColumbiaFloridaGeorgiaIowaIllinoisKentuckyLouisianaMarylandMichiganMinnesotaMissouriNorth CarolinaNew YorkOhioOklahomaOregonPennsylvania
Questions about this recall
Is Central Venous Catheter Tray Triple Lumen Polyurethane recalled?
Yes. Cook recalled Central Venous Catheter Tray Triple Lumen Polyurethane on 31 Jul 2017. The recall is Class II and its status is Terminated. Recall number Z-0631-2018.
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): 5919800 (30-May-2018)
Where was it sold?
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.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Skinny Needle with Chiba Tip recalled by Cook | Cook | Other | Nationwide |
| Device | CLASS II | Flexor Check-Flo Introducer Ansel Modification recalled by Cook | Cook | Labeling Errors | 14 states |
| Device | CLASS II | Flexor Check-Flo Introducer Ansel Modification recalled by Cook | Cook | Labeling Errors | 14 states |
| Device | CLASS II | Transseptal Needle, Trocar recalled by Cook | Cook | Device Malfunction | Nationwide |
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