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 by trained physicians in peripheral and coronary vascular system procedures, including procedures involving the carotid arteries. The recall affects 30 units with lot number NS9720276 and REF HNB5.0-35-100-P-8S-NEFF that were distributed worldwide, including across most U.S. states and multiple countries.
The affected products were distributed to locations in the United States, Australia, Belgium, Canada, China, Czech Republic, Denmark, France, Germany, Guatemala, Hong Kong, Italy, South Korea, Luxembourg, Mexico, Netherlands, Pakistan, Poland, South Africa, Spain, Sweden, Switzerland, Taiwan, and Great Britain. The source document does not specify a remedy or recommended action for consumers who may have received 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: 30 Lot/code info: REF (RPN): HNB5.0-35-100-P-8S-NEFF REF (GPN): G11026 Lot Number: NS9720276 UDI: (01)00827002110267(17)220516(10)NS9720276
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.