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 a potential compromise of sterility caused by an undersealed chevron in the packaging pouches. These catheters are intended for use in peripheral and coronary vascular procedures, including procedures involving the carotid arteries. The recall affects 10 units distributed worldwide, including nationwide distribution across most U.S. states and territories, as well as multiple countries including Australia, Canada, China, France, Germany, South Korea, Mexico, the United Kingdom, and others.
The affected products are from two specific lot numbers: 9700773 and 9705822, with specific reference and UDI codes identified. The source document 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: 10 Lot/code info: REF (RPN): HNB5.0-38-100-P-4S-NIH REF (GPN): G11749 Lot Numbers: 9700773, 9705822 UDIs: (01)00827002117495(17)220509(10)9700773, (01)00827002117495(17)220513(10)9705822
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.