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 by trained physicians in peripheral and coronary vascular procedures, including procedures involving the carotid arteries. A total of 20 units have been recalled across lot numbers NS9904021, NS9913224, and NS9945395, with distribution occurring nationwide throughout the United States and in multiple countries including Australia, Canada, China, France, Germany, Mexico, South Korea, and the United Kingdom.
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: 20 Lot/code info: REF (RPN): HNB5.0-38-65-P-NS-H1 REF (GPN): G06607 Lot Numbers: NS9904021, NS9913224, NS9945395 UDIs: (01)00827002066076(17)220801(10)NS9904021, (01)00827002066076(17)220802(10)NS9913224, (01)00827002066076(17)220823(10)NS9945395
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.