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 60 units of Torcon NB Advantage Catheters due to potential compromise of product sterility caused by an undersealed chevron in the packaging pouches. The affected catheters are intended for use in peripheral and coronary vascular system procedures, including the carotid arteries, by trained physicians. The recalled products have lot number 9914963 with specific reference numbers HNB5.0-38-65-P-2S-C2 and G06236.
The recalled catheters were distributed worldwide and throughout the United States, including in numerous states as well as Puerto Rico and countries including Canada, China, France, Germany, Mexico, South Korea, and the United Kingdom. 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: 60 Lot/code info: REF (RPN): HNB5.0-38-65-P-2S-C2 REF (GPN): G06236 Lot Number: 9914963 UDI: (01)00827002062368(17)220806(10)9914963
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.