Cook Inc. recalls Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifa…

Recall date

November 28, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0733-2017

FDA classification

Class II

Brand / firm

Cook Inc.

Sold / distributed

AZ CA DC GA IL LA MN MS NC NV NY OK PA TN TX WI

Why it was recalled

Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. Potential adverse events that may occur as a result of utilizing needles of incorrect size include delay in treatment, which could be critical in an emergent situation. There have been no reports of illness or injury associated with this issue.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray