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 undersealed chevrons in the packaging pouches. These catheters are intended for use in peripheral and coronary vascular procedures, including procedures involving the carotid arteries, and are used by trained physicians. The recall affects 100 units distributed worldwide, including nationwide distribution across most U.S. states and Puerto Rico, as well as distribution to Australia, Belgium, Canada, China, the Czech Republic, Denmark, France, Germany, Guatemala, Hong Kong, Italy, South Korea, Luxembourg, Mexico, the Netherlands, Pakistan, Poland, South Africa, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
The affected products are identified by reference number HNB5.0-38-110-P-12S-PED (RPN) and G13077 (GPN), with lot numbers 9700036 and 9707670. The source document does not specify a remedy or recommended action for consumers.
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: 100 Lot/code info: REF (RPN): HNB5.0-38-110-P-12S-PED REF (GPN): G13077 Lot Numbers: 9700036, 9707670 UDIs: (01)00827002130777(17)220509(10)9700036, (01)00827002130777(17)220515(10)9707670
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.