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 product 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 trained physicians. The recall affects 5 units with lot number NS9933623 and model reference HNB5.0-38-80-P-NS-JR1.5, which were distributed worldwide including across most U.S. states and multiple countries.
The affected products were distributed in the United States, Puerto Rico, and internationally to countries including Canada, Mexico, the United Kingdom, and others. The source does not specify a remedy or recommended action for consumers who may have received or used the 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: 5 Lot/code info: REF (RPN): HNB5.0-38-80-P-NS-JR1.5 REF (GPN): G30163 Lot Number: NS9933623 UDI: (01)00827002301634(17)220816(10)NS9933623
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.