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 sterility from an undersealed chevron in the packaging pouches. These catheters are intended for use by physicians in peripheral and coronary vascular procedures, including in the carotid arteries. A total of 951 units have been distributed worldwide, including across most U.S. states and Puerto Rico, as well as multiple countries in Europe, Asia, and other regions.
The affected catheters have specific lot numbers ranging from 9698823 to 9719485, with reference numbers HNB5.0-38-100-P-NS-H1 and G06005. The source document does not specify a remedy or instructions for what affected consumers should do.
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: 951 Lot/code info: REF (RPN): HNB5.0-38-100-P-NS-H1 REF (GPN): G06005 Lot Numbers: 9698823, 9702704, 9702705, 9702778, 9702809, 9703680, 9707588, 9714540, 9715463, 9716515, 9716516, 9716517, 9719485 UDIs: (01)00827002060050(17)220508(10)9698823, (01)00827002060050(17)220510(10)9702704, (01)00827002060050(17)220510(10)9702705, (01)00827002060050(17)220513(10)9702778, (01)00827002060050(17)220509(10)9702809, (01)00827002060050(17)220510(10)9703680, (01)00827002060050(17)220509(10)9707588, (01)00827002060050(17)220509(10)9714540, (01)00827002060050(17)220516(10)9715463, (01)00827002060050(17)220510(10)9716515, (01)00827002060050(17)220510(10)9716516, (01)00827002060050(17)220509(10)9716517, (01)00827002060050(17)220514(10)9719485
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.