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. recalled 45 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 system procedures, including procedures involving the carotid arteries. The recall was caused by an undersealed chevron in the packaging pouches of affected units.
The recalled catheters were distributed worldwide and throughout numerous U.S. states and countries including Australia, Canada, China, France, Germany, India, Japan, Mexico, the Netherlands, Poland, South Korea, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom. The affected products include eight specific lot numbers (NS9904742, NS9906243, NS9906244, NS9914968, NS9914970, NS9928941, NS9943480, and NS9943481). The source document does not specify what consumers or healthcare providers should do regarding this recall.
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: 45 Lot/code info: REF (RPN): HNB5.0-38-80-P-NS-HS2 REF (GPN): G10598 Lot Numbers: NS9904742, NS9906243, NS9906244, NS9914968, NS9914970, NS9928941, NS9943480, NS9943481 UDIs: (01)00827002105980(17)220731(10)NS9904742, (01)00827002105980(17)220731(10)NS9906243, (01)00827002105980(17)220801(10)NS9906244, (01)00827002105980(17)220805(10)NS9914968, (01)00827002105980(17)220805(10)NS9914970, (01)00827002105980(17)220809(10)NS9928941, (01)00827002105980(17)220826(10)NS9943480, (01)00827002105980(17)220822(10)NS9943481
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.