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): HNB5.0-38-80-P-NS-C2 REF (GPN): G05955 Lot Numbers: 9916981, 9924484, 9924486, 9943478, 9943643, 9943644, 9944133, 9946873, 9946875, 9947569, 9949557, 9949558, 9952694, NS9938577 UDIs: (01)00827002059559(17)220805(10)9916981, (01)00827002059559(17)220807(10)9924484, (01)00827002059559(17)220807(10)9924486, (01)00827002059559(17)220823(10)9943478, (01)00827002059559(17)220822(10)9943643, (01)00827002059559(17)220822(10)9943644, (01)00827002059559(17)220822(10)9944133, (01)00827002059559(17)220822(10)9946873, (01)00827002059559(17)220823(10)9946875, (01)00827002059559(17)220822(10)9947569, (01)00827002059559(17)220822(10)9949557, (01)00827002059559(17)220823(10)9949558, (01)00827002059559(17)220823(10)9952694, (01)00827002059559(17)220816(10)NS9938577
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