Home / Recalls / Cook Inc. / Z-0634-2018

Z-0634-2018 Class II Terminated

Recalled by Cook Inc. — Bloomington, IN

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),

Other recalls by Cook Inc.

  • Z-0388-2022 Class II — Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45- (November 12, 2021)
  • Z-0387-2022 Class II — Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45 (November 12, 2021)
  • Z-0414-2022 Class II — Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigi (October 13, 2021)
  • Z-0223-2022 Class II — Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxi (October 8, 2021)
  • Z-0222-2022 Class II — Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. (October 8, 2021)
  • Z-0186-2022 Class II — Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-3 (September 28, 2021)
  • Z-0185-2022 Class II — Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 (September 28, 2021)
  • Z-0960-2021 Class II — Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retr (January 4, 2021)
  • Z-0610-2021 Class I — Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-S (November 24, 2020)
  • Z-0594-2021 Class I — Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G5623 (November 24, 2020)