Recall Z-0634-2018— Cook Inc.

Name: FDA recall Z-0634-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-31

Class II · Terminated

Class II FDA medical device recall by Cook Inc., initiated 2017-07-31, terminated 2019-05-08. It names one FDA 510(k) clearance: K033843. Product: 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: Central venous catheters may not fit over guide wire potentially causing procedure delay..

Recalling firm: Cook Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-07-31
Terminated: 2019-05-08
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K033843 — SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATINGCook, Inc.·cleared 2004-08-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.