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 35 Torcon NB Advantage Catheters used by physicians in peripheral and coronary vascular procedures, including procedures involving the carotid arteries. The catheters were distributed worldwide, including across most U.S. states and multiple countries. The recall was issued because of a potential compromise to the sterility of the products caused by an undersealed chevron in the packaging pouches.
The affected product is identified by Reference Number HNB5.0-35-65-P-NS-TIPS (RPN) and G19706 (GPN), with Lot Number 9890919 and UDI (01)00827002197060(17)220729(10)9890919. The recall notice does not specify a remedy or what consumers should do if they have this product.
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: 35 Lot/code info: REF (RPN): HNB5.0-35-65-P-NS-TIPS REF (GPN): G19706 Lot Number: 9890919 UDI: (01)00827002197060(17)220729(10)9890919
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.