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. recalled 165 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 by trained physicians in peripheral and coronary vascular system procedures, including procedures involving the carotid arteries. The affected products were distributed worldwide, including across numerous U.S. states and multiple countries.
The recall involves three specific lot numbers: 9700385, 9713001, and 9726999, with corresponding UDI codes provided for identification. The product recall record 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: 165 Lot/code info: REF (RPN): HNB5.0-38-100-P-NS-SIM1 REF (GPN): G04922 Lot Numbers: 9700385, 9713001, 9726999 UDIs: (01)00827002049222(17)220509(10)9700385, (01)00827002049222(17)220516(10)9713001, (01)00827002049222(17)220515(10)9726999
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.