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): HNB6.0-38-65-P-NS-BMC REF (GPN): G32465 Lot Numbers: 9908469, 9911359, 9936124 UDIs: (01)00827002324657(17)220805(10)9908469, (01)00827002324657(17)220805(10)9911359, (01)00827002324657(17)220821(10)9936124
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