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-JL3.5 REF (GPN): G05924 Lot Numbers: 9705826, 9707669, 9709326, 9714955, 9716791, 9717961, NS9718543 UDIs: (01)00827002059245(17)220516(10)9705826, (01)00827002059245(17)220513(10)9707669, (01)00827002059245(17)220515(10)9709326, (01)00827002059245(17)220516(10)9714955, (01)00827002059245(17)220510(10)9716791, (01)00827002059245(17)220511(10)9717961, (01)00827002059245(17)220516(10)NS9718543

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