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 used by physicians in peripheral and coronary vascular procedures, including those involving the carotid arteries. The recall affects 25 units distributed worldwide, including across numerous U.S. states, Puerto Rico, and countries including Canada, China, France, Germany, Mexico, South Korea, and the United Kingdom. The specific recalled lot is identified as Lot Number 9718544 with reference number HNB5.0-38-100-P-NS-JR5.
The catheters are being recalled due to a potential compromise of sterility resulting from an undersealed chevron in the packaging pouches. The recall notice 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: 25 Lot/code info: REF (RPN): HNB5.0-38-100-P-NS-JR5 REF (GPN): G10727 Lot Number: 9718544 UDI: (01)00827002107274(17)220516(10)9718544
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.