Cook Inc.: Medical Device Recall in 2018 - (Recall #: Z-0631-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: July 31, 2017

Date Posted: February 21, 2018

Recall Number: Z-0631-2018

Event ID: 79050

Reason for Recall:

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

Status: Terminated

Product Quantity: 25

Code Information:

Lot Number (Expiration date): 5919800 (30-May-2018)

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated