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 230 Torcon NB Advantage Catheters due to potential compromise of sterility in the product packaging. The catheters are intended for use in peripheral and coronary vascular system procedures, including the carotid arteries, performed by trained physicians. The problem stems from an undersealed chevron in the packaging pouches of affected units.
The affected catheters were distributed worldwide and throughout numerous U.S. states and territories, as well as in countries including Australia, Belgium, Canada, China, Denmark, France, Germany, and others. The recall involves three specific lot numbers (9908469, 9911359, and 9936124) with reference number HNB6.0-38-65-P-NS-BMC. The source document does not specify a remedy or instructions for what affected consumers should do.
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: 230 Lot/code info: REF (RPN): HNB6.0-38-65-P-NS-BMC REF (GPN): G32465 Lot Numbers: 9908469, 9911359, 9936124 UDIs: (01)00827002324657(17)220805(10)9908469, (01)00827002324657(17)220805(10)9911359, (01)00827002324657(17)220821(10)9936124
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.