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 system procedures, including procedures involving the carotid arteries. The recall affects ten units distributed worldwide, including to numerous U.S. states and several countries. The specific lot involved is identified by lot number NS9904740, with additional identifying information including REF codes HNB5.0-38-80-P-NS-EKISAI-111984 and G10796.
The catheters are being recalled because of a potential compromise to the sterility of the products caused by an undersealed chevron in the packaging pouches. The source document does not specify what actions affected consumers should take.
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): HNB5.0-38-80-P-NS-EKISAI-111984 REF (GPN): G10796 Lot Number: NS9904740 UDI: (01)00827002107960(17)220801(10)NS9904740
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.