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 catheters are affected by a potential sterility compromise resulting from an undersealed chevron in the packaging pouches. The recall affects 10 units with lot number NS9939355 and specific product codes HNB5.0-38-80-P-NS-RIM and G10885.
The affected catheters were distributed worldwide and throughout numerous U.S. states, as well as in multiple countries including 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 source document does not specify a remedy or recommended action for affected 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: 10 Lot/code info: REF (RPN): HNB5.0-38-80-P-NS-RIM REF (GPN): G10885 Lot Number: NS9939355 UDI: (01)00827002108851(17)220820(10)NS9939355
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.