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-HN5 REF (GPN): G07300 Lot Numbers: NS9700775, NS9705496, NS9710350, NS9713694 UDIs: (01)00827002073005(17)220511(10)NS9700775, (01)00827002073005(17)220509(10)NS9705496, (01)00827002073005(17)220515(10)NS9710350, (01)00827002073005(17)220514(10)NS9713694
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