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 90 Torcon NB Advantage Catheters due to a potential compromise of product sterility caused by an undersealed chevron in the packaging pouches. These catheters are intended for use by trained physicians in peripheral and coronary vascular system procedures, including procedures involving the carotid arteries. The affected products were distributed worldwide, including throughout most of the United States and in numerous countries including Australia, Canada, China, France, Germany, Mexico, the Netherlands, Poland, South Korea, Spain, Switzerland, Taiwan, and the United Kingdom.
The recalled catheters are identified by reference number HNB5.0-38-100-P-NS-JL4 and GPN G05923, with lot numbers 9700383 and NS9701376. The source document does not specify a remedy or instructions for what affected consumers should do regarding this recall.
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: 90 Lot/code info: REF (RPN): HNB5.0-38-100-P-NS-JL4 REF (GPN): G05923 Lot Numbers: 9700383, NS9701376 UDIs: (01)00827002059238(17)220510(10)9700383, (01)00827002059238(17)220508(10)NS9701376
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.