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. has recalled Torcon NB Advantage Catheters, which are medical devices used by physicians in blood vessel procedures involving the peripheral and coronary vascular system, including the carotid arteries. The recall involves 1,125 units of these catheters due to a potential compromise of sterility caused by an undersealed chevron in the packaging pouches. The affected catheters were distributed worldwide, including across most U.S. states and territories, as well as in multiple countries including Australia, Canada, China, France, Germany, Mexico, South Korea, and the United Kingdom.
The specific lot numbers affected by this recall are 9916981, 9924484, 9924486, 9943478, 9943643, 9943644, 9944133, 9946873, 9946875, 9947569, 9949557, 9949558, 9952694, and NS9938577. The source document does not specify what actions affected consumers should take in response to 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: 1,125 Lot/code info: REF (RPN): HNB5.0-38-80-P-NS-C2 REF (GPN): G05955 Lot Numbers: 9916981, 9924484, 9924486, 9943478, 9943643, 9943644, 9944133, 9946873, 9946875, 9947569, 9949557, 9949558, 9952694, NS9938577 UDIs: (01)00827002059559(17)220805(10)9916981, (01)00827002059559(17)220807(10)9924484, (01)00827002059559(17)220807(10)9924486, (01)00827002059559(17)220823(10)9943478, (01)00827002059559(17)220822(10)9943643, (01)00827002059559(17)220822(10)9943644, (01)00827002059559(17)220822(10)9944133, (01)00827002059559(17)220822(10)9946873, (01)00827002059559(17)220823(10)9946875, (01)00827002059559(17)220822(10)9947569, (01)00827002059559(17)220822(10)9949557, (01)00827002059559(17)220823(10)9949558, (01)00827002059559(17)220823(10)9952694, (01)00827002059559(17)220816(10)NS9938577
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.