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 10 Torcon NB Advantage Catheters due to potential compromise of product sterility caused by an undersealed chevron in the packaging pouches. These catheters are intended for use by trained physicians in peripheral and coronary vascular procedures, including procedures involving the carotid arteries. The affected devices were distributed worldwide, including throughout most U.S. states and multiple countries.
The recalled catheters have specific lot numbers NS9913495 and NS9930288, with corresponding UDI codes and reference numbers HNB5.0-35-80-P-2S-C2 and G06622. The source record 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): HNB5.0-35-80-P-2S-C2 REF (GPN): G06622 Lot Numbers: NS9913495, NS9930288 UDIs: (01)00827002066229(17)220805(10)NS9913495, (01)00827002066229(17)220812(10)NS9930288
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.