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Recall Observatory FDA recall evidence

Device product

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

Z-0632-2018

July 31, 2017

Class II

Product summary

Firm
Cook Inc.
Event
Event 79050
Status
Terminated
Classification
Class II
Quantity
75
Official record key
device-enforcement:Z-0632-2018

Official wording

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

Code information: Lot Number (Expiration date): NS5914753 (28-May-2018), 7252432 (23-September-2017), 7252434 (23-September-2017), 7621767 (06-February-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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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