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.
Check against the official notice below — it lists the full affected range.
Cook Inc. is recalling 1,679 units of Torcon NB Advantage Catheters due to potential compromise of sterility caused by an undersealed chevron in the packaging pouches. These catheters are intended for use in peripheral and coronary vascular procedures, including the carotid arteries. The affected products were distributed worldwide, including across most U.S. states, Puerto Rico, and multiple international countries. The recall involves 19 specific lot numbers with reference numbers HNB5.0-38-100-P-NS-DAV and G08895.
The affected lot numbers are 9693495, 9701375, 9703638, 9703647, 9703648, 9708138, 9708139, 9708140, 9708542, 9709228, 9709932, 9712996, 9715458, 9715462, 9715468, 9715469, 9716505, 9733722, and 9734096. The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Reason for recall: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB. Quantity: 1,679 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.