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 recall affects 20 catheters with specific lot numbers (NS9715223 and NS9718545) that were distributed nationwide across the United States, Puerto Rico, and multiple countries including Australia, Canada, China, France, Germany, Mexico, South Korea, and the United Kingdom.
The catheters are being recalled because the packaging pouches may have an undersealed chevron, which could compromise the sterility of the products. The recall notice does not specify a remedy or recommended course of 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: 20 Lot/code info: REF (RPN): HNB5.0-38-100-P-NS-JIM REF (GPN): G06039 Lot Numbers: NS9715223, NS9718545 UDIs: (01)00827002060395(17)220515(10)NS9715223, (01)00827002060395(17)220516(10)NS9718545
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.