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 95 Torcon NB Advantage Catheters due to potential compromise of product sterility caused by an undersealed chevron in the packaging pouches. These catheters are used by trained physicians in peripheral and coronary vascular system procedures, including carotid artery procedures. The affected product has a specific lot number (9712522) and was distributed worldwide, including across most U.S. states and numerous countries such as Canada, the United Kingdom, Australia, China, France, Germany, Mexico, and South Korea.
The recall record does not specify a remedy or 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: 95 Lot/code info: REF (RPN): HNB5.0-38-100-P-NS-VTK REF (GPN): G10756 Lot Number: 9712522 UDI: (01)00827002107564(17)220516(10)9712522
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.