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 five units distributed worldwide, including throughout most U.S. states and multiple countries. The catheters are being recalled due to potential compromised sterility resulting from an undersealed chevron in the packaging pouches.
The affected product has Reference number HNB5.0-38-65-P-NS-TC-01, GPN G47192, Lot Number 9903996, with the specific UDI (01)00827002471924(17)220801(10)9903996. The source document does not specify a remedy or recommend 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: 5 Lot/code info: REF (RPN): HNB5.0-38-65-P-NS-TC-01 REF (GPN): G47192 Lot Number: 9903996 UDI: (01)00827002471924(17)220801(10)9903996
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.