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 in the product packaging. The catheters are intended for use in peripheral and coronary vascular procedures, including in the carotid arteries, and are used by trained physicians. The issue stems from an undersealed chevron in the packaging pouches. The recalled products were distributed worldwide, including throughout most U.S. states and Puerto Rico, as well as in multiple countries including Australia, Canada, China, France, Germany, South Korea, Mexico, the Netherlands, Poland, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
Twenty-five units of the affected product are involved in this recall. The specific lot information is Lot Number 9903997, with reference numbers HNB5.0-38-80-P-NS-MIK and G06108, and a UDI of (01)00827002061088(17)220801(10)9903997. The source document does not specify a remedy or action for affected consumers to take.
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: 25 Lot/code info: REF (RPN): HNB5.0-38-80-P-NS-MIK REF (GPN): G06108 Lot Number: 9903997 UDI: (01)00827002061088(17)220801(10)9903997
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.