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-DAV REF (GPN): G08895 Lot Numbers: 9693495, 9701375, 9703638, 9703647, 9703648, 9708138, 9708139, 9708140, 9708542, 9709228, 9709932, 9712996, 9715458, 9715462, 9715468, 9715469, 9716505, 9733722, 9734096 UDIs: (01)00827002088955(17)220508(10)9693495, (01)00827002088955(17)220510(10)9701375, (01)00827002088955(17)220510(10)9703638, (01)00827002088955(17)220510(10)9703647, (01)00827002088955(17)220510(10)9703648, (01)00827002088955(17)220513(10)9708138, (01)00827002088955(17)220514(10)9708139, (01)00827002088955(17)220514(10)9708140, (01)00827002088955(17)220513(10)9708542, (01)00827002088955(17)220516(10)9709228, (01)00827002088955(17)220514(10)9709932, (01)00827002088955(17)220516(10)9712996, (01)00827002088955(17)220516(10)9715458, (01)00827002088955(17)220517(10)9715462, (01)00827002088955(17)220516(10)9715468, (01)00827002088955(17)220517(10)9715469, (01)00827002088955(17)220517(10)9716505, (01)00827002088955(17)220524(10)9733722, (01)00827002088955(17)220523(10)9734096
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