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-H1 REF (GPN): G06005 Lot Numbers: 9698823, 9702704, 9702705, 9702778, 9702809, 9703680, 9707588, 9714540, 9715463, 9716515, 9716516, 9716517, 9719485 UDIs: (01)00827002060050(17)220508(10)9698823, (01)00827002060050(17)220510(10)9702704, (01)00827002060050(17)220510(10)9702705, (01)00827002060050(17)220513(10)9702778, (01)00827002060050(17)220509(10)9702809, (01)00827002060050(17)220510(10)9703680, (01)00827002060050(17)220509(10)9707588, (01)00827002060050(17)220509(10)9714540, (01)00827002060050(17)220516(10)9715463, (01)00827002060050(17)220510(10)9716515, (01)00827002060050(17)220510(10)9716516, (01)00827002060050(17)220509(10)9716517, (01)00827002060050(17)220514(10)9719485
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