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, and are used by trained physicians. The recall affects five units with lot number NS9939340 and specific reference numbers, distributed worldwide including across most U.S. states, Puerto Rico, and multiple countries including Australia, Canada, China, France, Germany, Mexico, South Korea, the United Kingdom, and others.
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: 5 Lot/code info: REF (RPN): HNB5.0-35-80-P-2S-C1 REF (GPN): G09875 Lot Number: NS9939340 UDI: (01)00827002098756(17)220816(10)NS9939340
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.