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 20 Torcon NB Advantage Catheters used by physicians in peripheral and coronary vascular procedures, including procedures involving the carotid arteries. The catheters are affected by a potential sterility compromise due to an undersealed chevron in the packaging pouches. The recalled lot includes two lot numbers (9926069 and NS9926068) with reference numbers HNB5.0-38-80-P-NS-C3 and G09521, and the affected catheters were distributed worldwide and throughout most U.S. states, as well as multiple international countries.
The source document does not specify a remedy or recommended action for consumers who may have affected 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: 20 Lot/code info: REF (RPN): HNB5.0-38-80-P-NS-C3 REF (GPN): G09521 Lot Numbers: 9926069, NS9926068 UDIs: (01)00827002095212(17)220822(10)9926069, (01)00827002095212(17)220809(10)NS9926068
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.