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 in peripheral and coronary vascular procedures, including those involving the carotid arteries. The recall affects five units with lot number 9707476 and specific product reference numbers due to a potential compromise of product sterility caused by an undersealed chevron in the packaging pouches. The affected catheters were distributed worldwide, including throughout most U.S. states, Puerto Rico, and multiple countries including Australia, Canada, China, France, Germany, Mexico, South Korea, and the United Kingdom.
The record does not specify a remedy for consumers who may have affected units.
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): HNB5.0-38-100-P-NS-AR1 REF (GPN): G10751 Lot Number: 9707476 UDI: (01)00827002107519(17)220514(10)9707476
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.