Cook Central Venous Catheter Recall: Potential Procedure Delay Risk
Cook recalls Central Venous Tray Triple Lumen Polyurethane Catheter (C-UTLMY-501J-CCT) due to possible procedure delays if not fitting over guide wire. Affected units sold to hospitals and critical care facilities.
Lower-risk recall
Central venous catheters may not fit over guide wire potentially causing procedure delay.
Contact the company
What happened, in plain English
Cook is recalling a central venous catheter used in hospitals for critical patients because it may not fit properly over guide wires, potentially causing procedure delays. This affects medical devices used in hospitals for drug infusions, blood monitoring, and blood product delivery. Read more at govinfonow.com/recall/73275-cook-central-venous-catheter-recall-potential-procedure-delay-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73275-cook-central-venous-catheter-recall-potential-procedure-delay-risk · Updated September 19, 2026 · FDA enforcement record: FDA #Z-0633-2018
Cite this page
“Cook Central Venous Catheter Recall: Potential Procedure Delay Risk.” GovInfoNow, updated September 19, 2026. https://govinfonow.com/recall/73275-cook-central-venous-catheter-recall-potential-procedure-delay-risk. Based on FDA recall #Z-0633-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0633-2018%22&limit=1).
Why it’s dangerous
The catheter may not fit correctly over guide wires during medical procedures, which could cause delays in critical treatments. This is a potential issue for procedures requiring continuous or intermittent drug infusions, blood monitoring, or blood product delivery.
Who’s affected
Hospitals and critical care facilities that use this catheter for drug infusions, blood monitoring, or blood product delivery. Patients receiving treatment with this device are most at risk.
How to tell if you have this one
Look for the catalog identifier C-UTLMY-501J-CCT on the catheter. This product was sold to hospitals and critical care facilities with lot number 5901462 (expiring January 30, 2018).
- Brand
Cook- Category
Medical device
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0630-2018 | Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-UTLM-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; Lot Number (Expiration date): 5918090 (29-May-2018), 5925813 (02-June-2018) | 85 |
| Z-0631-2018 | 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; Lot Number (Expiration date): 5919800 (30-May-2018) | 25 |
| Z-0632-2018 | Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog Identifiers: C-UTLM-501J-25-6.5-WCE-BH, C-UTLM-501J-BH 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; Lot Number (Expiration date): NS5914753 (28-May-2018), 7252432 (23-September-2017), 7252434 (23-September-2017), 7621767 (06-February-2018) | 75 |
| Z-0633-2018 | 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; Lot Number (Expiration date): 5901462 (30-January-2018) | 50 |
| Z-0634-2018 | Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Catalog Identifiers: C-UTLMY-501J-ABRM-HC-FST and C-UTLMY-501J-ABRM-HC-IHI-FST Usage: The Spectrum Central Venous Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents, and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring; Lot Number (Expiration date): 7693203 (01-May-2019), 7611811 (01-May-2019), 7625110 (01-May-2019), 7625111 (01-May-2019), 7689802 (01-May-2019), 7713113 (01-May-2019), and 7724842 (01-September-2019), | 304 |
What to do — step by step
Check Product Details
Verify the catalog identifier C-UTLMY-501J-CCT on the catheter to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 26 states.
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Iowa, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0633-2018 (July 31, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0633-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.