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 Torcon NB Advantage Catheters due to potential compromise of product sterility caused by an undersealed chevron in the packaging pouches. These catheters are intended for use by trained physicians in peripheral and coronary vascular procedures, including procedures involving the carotid arteries. The recall affects 10 units with lot numbers NS9712997 and NS9712998, distributed worldwide across numerous U.S. states, U.S. territories, and international countries including Canada, Mexico, Australia, and several European and Asian nations.
The affected products are identified by reference number HNB5.0-38-100-P-NS-JR2 and GPN G10924. The source document does not specify a remedy or recommended action for consumers who may have affected products.
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: 10 Lot/code info: REF (RPN): HNB5.0-38-100-P-NS-JR2 REF (GPN): G10924 Lot Numbers: NS9712997, NS9712998 UDIs: (01)00827002109247(17)220516(10)NS9712997, (01)00827002109247(17)220515(10)NS9712998
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.