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 470 Torcon NB Advantage Catheters due to potential compromise of product sterility caused by undersealed chevrons 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 products were distributed worldwide, including nationwide distribution across most U.S. states and Puerto Rico, as well as international distribution to countries including Australia, Canada, China, France, Germany, Hong Kong, Italy, Mexico, South Korea, the Netherlands, Poland, Spain, Switzerland, Taiwan, and the United Kingdom.
The recalled catheters are identified by reference numbers HNB5.0-38-100-P-NS-MPA and G08153, with lot numbers 9696901, 9700384, 9701377, 9708543, and 9709229. The specific UDIs for each lot are listed in the recall record. The source document 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: 470 Lot/code info: REF (RPN): HNB5.0-38-100-P-NS-MPA REF (GPN): G08153 Lot Numbers: 9696901, 9700384, 9701377, 9708543, 9709229 UDIs: (01)00827002081536(17)220508(10)9696901, (01)00827002081536(17)220513(10)9700384, (01)00827002081536(17)220509(10)9701377, (01)00827002081536(17)220514(10)9708543, (01)00827002081536(17)220509(10)9709229
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.