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 10 units with lot number 9908502 due to a potential compromise of sterility caused by an undersealed chevron in the packaging pouches. The affected catheters were distributed worldwide, including across most U.S. states and territories, as well as numerous countries in Europe, Asia, and other regions.
The product recall record does not specify a remedy or recommended action for consumers who may have received affected units.
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: 10 Lot/code info: REF (RPN): HNB5.0-38-65-P-NS-KMP-01 REF (GPN): G47185 Lot Number: 9908502 UDI: (01)00827002471856(17)220808(10)9908502
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.