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-10S-0 REF (GPN): G07268 Lot Numbers: 9693491, 9696896, 9700377, 9700378, 9700379, 9710398, 9716496, NS9712994 UDIs: (01)00827002072688(17)220508(10)9693491, (01)00827002072688(17)220508(10)9696896, (01)00827002072688(17)220508(10)9700377, (01)00827002072688(17)220509(10)9700378, (01)00827002072688(17)220510(10)9700379, (01)00827002072688(17)220515(10)9710398, (01)00827002072688(17)220517(10)9716496, (01)00827002072688(17)220516(10)NS9712994

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