medical Class II Updated 2019-11-27

Cook Inc. recalls Torcon NB Advantage Catheters - Product Usage: Intended for

Recalled Product

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

Hazard / Issue

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: REF (RPN): HNB5.0-38-100-P-NS-JR4 REF (GPN): G05922 Lot Numbers: 9700390, 9705827, 9709327, 9710351, 9715466, 9715476, 9716493, 9716792, 9719152 UDIs: (01)00827002059221(17)220508(10)9700390, (01)00827002059221(17)220513(10)9705827, (01)00827002059221(17)220513(10)9709327, (01)00827002059221(17)220514(10)9710351, (01)00827002059221(17)220516(10)9715466, (01)00827002059221(17)220516(10)9715476, (01)00827002059221(17)220517(10)9716493, (01)00827002059221(17)220509(10)9716792, (01)00827002059221(17)220511(10)9719152

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