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 those involving the carotid arteries. The recall affects five units with lot number NS9906245 distributed worldwide, including across all U.S. states and territories, as well as countries including Australia, Canada, China, France, Germany, South Korea, Mexico, the Netherlands, Poland, Spain, Switzerland, Taiwan, and the United Kingdom.
The catheters are being recalled due to potential compromise of product sterility caused by undersealed chevrons in the packaging pouches. The affected product has reference number HNB5.0-38-80-P-NS-JR2.5 and GPN G08985. The recall source does not specify a remedy or instructions 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): HNB5.0-38-80-P-NS-JR2.5 REF (GPN): G08985 Lot Number: NS9906245 UDI: (01)00827002089853(17)220801(10)NS9906245
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.