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): HNB5.0-38-110-P-12S-PIG REF (GPN): G10741 Lot Numbers: 9706696, 9707671, 9709328, 9711384, 9718538 UDIs: (01)00827002107410(17)220513(10)9706696, (01)00827002107410(17)220514(10)9707671, (01)00827002107410(17)220515(10)9709328, (01)00827002107410(17)220515(10)9711384, (01)00827002107410(17)220516(10)9718538

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