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-PED REF (GPN): G13077 Lot Numbers: 9700036, 9707670 UDIs: (01)00827002130777(17)220509(10)9700036, (01)00827002130777(17)220515(10)9707670
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