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 sterility compromise caused by an undersealed chevron in the packaging pouches. These catheters are intended for use by trained physicians in peripheral and coronary vascular system procedures, including carotid artery procedures. The affected products have lot numbers NS9906320 and NS9906321, reference number HNB5.0-38-80-P-NS-JR2, and were distributed worldwide to numerous U.S. states and countries including Australia, Canada, France, Germany, Mexico, South Korea, and the United Kingdom.
The recall record does not specify any remedy, such as instructions for return, replacement, or other corrective action that affected consumers should take.
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): HNB5.0-38-80-P-NS-JR2 REF (GPN): G10733 Lot Numbers: NS9906320, NS9906321 UDIs: (01)00827002107335(17)220731(10)NS9906320, (01)00827002107335(17)220801(10)NS9906321
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.