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 recall affects 10 units distributed worldwide, including across nearly all U.S. states and Puerto Rico, as well as multiple countries in Europe, Asia, and other regions. The catheters are being recalled because the packaging pouches may have an undersealed chevron that could compromise the sterility of the product.
The affected product has reference number HNB5.0-38-65-P-2S-C1, lot number NS9906241, and UDI (01)00827002068278(17)220801(10)NS9906241. The source document does not specify what action 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): HNB5.0-38-65-P-2S-C1 REF (GPN): G06827 Lot Number: NS9906241 UDI: (01)00827002068278(17)220801(10)NS9906241
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.