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-JL3 REF (GPN): G10998 Lot Numbers: 9712521, 9732872, NS9717350 UDIs: (01)00827002109988(17)220516(10)9712521, (01)00827002109988(17)220517(10)9732872, (01)00827002109988(17)220517(10)NS9717350

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