Z-0634-2018 Class II Terminated
FDA device recall Z-0634-2018 was initiated by Cook Inc. on July 31, 2017 and is designated Class II. Reason for recall: Central venous catheters may not fit over guide wire potentially causing procedure delay. The recall status is terminated (terminated May 8, 2019). Affected quantity: 304.
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- July 31, 2017
- Termination Date
- May 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 304
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
Reason for Recall
Central venous catheters may not fit over guide wire potentially causing procedure delay.
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.
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),