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-VERT REF (GPN): G06074 Lot Numbers: 9696580, 9707470, 9707471, 9710400, 9710402, 9710403, 9710404, 9710405, 9734099, NS9710401 UDIs: (01)00827002060746(17)220508(10)9696580, (01)00827002060746(17)220513(10)9707470, (01)00827002060746(17)220514(10)9707471, (01)00827002060746(17)220515(10)9710400, (01)00827002060746(17)220516(10)9710402, (01)00827002060746(17)220515(10)9710403, (01)00827002060746(17)220515(10)9710404, (01)00827002060746(17)220514(10)9710405, (01)00827002060746(17)220524(10)9734099, (01)00827002060746(17)220513(10)NS9710401

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