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 250 Torcon NB Advantage Catheters due to potential compromise of sterility in the product packaging. These catheters are intended for use by trained physicians in peripheral and coronary vascular procedures, including procedures involving the carotid arteries. The problem stems from an undersealed chevron in the packaging pouches. The affected products were distributed worldwide, including throughout most U.S. states and territories, as well as multiple countries in Europe, Asia, Africa, and the Americas.
The recall involves three specific lot numbers: 9712995, 9726996, and NS9700766. Affected products can be identified by their reference numbers (HNB5.0-38-100-P-NS-JB1 and G05997) and their unique device identifiers listed in the recall notice. The source document does not specify what action affected consumers or healthcare providers should take in response to this recall.
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: 250 Lot/code info: REF (RPN): HNB5.0-38-100-P-NS-JB1 REF (GPN): G05997 Lot Numbers: 9712995, 9726996, NS9700766 UDIs: (01)00827002059979(17)220516(10)9712995, (01)00827002059979(17)220516(10)9726996, (01)00827002059979(17)220508(10)NS9700766
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.