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 procedures involving the carotid arteries. The recall affects five units distributed worldwide, including across nearly all U.S. states and territories as well as multiple countries. The specific recalled lot is identified by lot number NS9705494 with reference numbers HNB5.0-35-100-P-NS-JR2 and G27617.
The reason for the recall is a potential compromise of product sterility caused by an undersealed chevron in the packaging pouches of the catheters. The source document does not specify any remedy or corrective action 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: 5 Lot/code info: REF (RPN): HNB5.0-35-100-P-NS-JR2 REF (GPN): G27617 Lot Number: NS9705494 UDI: (01)00827002276178(17)220510(10)NS9705494
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.