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 a potential compromise of sterility in the product packaging. The catheters are intended for use by trained physicians in peripheral and coronary vascular procedures, including those involving the carotid arteries. The recall affects 145 units with specific lot numbers (9700004, 9703928, and NS9703929) that were distributed nationwide across multiple U.S. states, Puerto Rico, and numerous international countries including Canada, China, France, Germany, South Korea, Mexico, and the United Kingdom.
The sterility issue stems from an undersealed chevron in the packaging pouches of the affected catheters. The record does not specify a remedy for consumers or healthcare facilities who may have received these products.
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: 145 Lot/code info: REF (RPN): HNB5.0-35-100-P-10S-PIG REF (GPN): G08201 Lot Numbers: 9700004, 9703928, NS9703929 UDIs: (01)00827002082014(17)220511(10)9700004, (01)00827002082014(17)220510(10)9703928, (01)00827002082014(17)220508(10)NS9703929
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.