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 potential compromised sterility caused by undersealed chevrons in the packaging pouches. These catheters are intended for use in peripheral and coronary vascular system procedures, including carotid artery procedures, by trained physicians. The affected products have lot number NS9933578 and were distributed worldwide, including throughout the United States and multiple countries including Canada, the United Kingdom, Mexico, Australia, and others.
Ten units of the recalled catheters are affected, identified by reference number HNB5.0-38-65-P-1S-VA-070793 and GPN G12783. The source document does not specify a remedy or instructions for what affected consumers should do regarding 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: 10 Lot/code info: REF (RPN): HNB5.0-38-65-P-1S-VA-070793 REF (GPN): G12783 Lot Number: NS9933578 UDI: (01)00827002127838(17)220812(10)NS9933578
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.