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 due to a potential compromise of sterility caused by an undersealed chevron in the packaging pouches. These catheters are intended for use in peripheral and coronary vascular system procedures, including the carotid arteries, and are used by physicians during angiographic procedures. The recall affects 135 units with lot numbers 9714956 and 9719147, distributed worldwide including across most U.S. states and multiple countries.
The source document does not specify a remedy or corrective action for consumers who may have affected catheters.
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: 135 Lot/code info: REF (RPN): HNB5.0-38-100-P-NS-JR3 REF (GPN): G10930 Lot Numbers: 9714956, 9719147 UDIs: (01)00827002109308(17)220516(10)9714956, (01)00827002109308(17)220513(10)9719147
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.