Cook Inc.: Medical Device Recall in 2018 - (Recall #: Z-0634-2018)

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:

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

Product Classification:

Class II

Date Initiated: July 31, 2017

Date Posted: February 21, 2018

Recall Number: Z-0634-2018

Event ID: 79050

Reason for Recall:

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

Status: Terminated

Product Quantity: 304

Code Information:

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),

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