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, which are medical devices intended for use in blood vessels during diagnostic procedures performed by trained physicians. The catheters are used in the peripheral and coronary vascular system, including the carotid arteries. The recall affects 311 units distributed worldwide, including nationwide distribution across most U.S. states, Puerto Rico, and multiple countries including Australia, Canada, China, France, Germany, Mexico, South Korea, and the United Kingdom.
The recall was initiated due to a potential compromise of product sterility caused by an undersealed chevron in the packaging pouches. This defect could allow the catheter to become contaminated before use. The affected products have specific lot numbers (9693491, 9696896, 9700377, 9700378, 9700379, 9710398, 9716496, and NS9712994) with reference numbers HNB5.0-38-100-P-10S-0 and G07268. The source document does not specify a remedy or what action affected consumers should take.
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: 311 Lot/code info: REF (RPN): HNB5.0-38-100-P-10S-0 REF (GPN): G07268 Lot Numbers: 9693491, 9696896, 9700377, 9700378, 9700379, 9710398, 9716496, NS9712994 UDIs: (01)00827002072688(17)220508(10)9693491, (01)00827002072688(17)220508(10)9696896, (01)00827002072688(17)220508(10)9700377, (01)00827002072688(17)220509(10)9700378, (01)00827002072688(17)220510(10)9700379, (01)00827002072688(17)220515(10)9710398, (01)00827002072688(17)220517(10)9716496, (01)00827002072688(17)220516(10)NS9712994
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.