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 used by physicians in peripheral and coronary vascular procedures, including procedures involving the carotid arteries. The catheters were distributed worldwide and across numerous U.S. states and countries. The recall involves five units of a specific lot (Lot Number 9716495) identified by reference number HNB5.0-38-100-P-NS-JL2 and GPN G09757.
The catheters are being recalled due to potential compromise of product sterility caused by an undersealed chevron in the packaging pouches. The source document does not specify a remedy or any recommended action for affected consumers.
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: 5 Lot/code info: REF (RPN): HNB5.0-38-100-P-NS-JL2 REF (GPN): G09757 Lot Number: 9716495 UDI: (01)00827002097575(17)220517(10)9716495
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.