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 30 Torcon NB Advantage Catheters due to a potential compromise of product sterility caused by an undersealed chevron 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 product has the reference number HNB5.0-38-80-P-NS-RC1, GPN G11543, lot number 9906464, and was distributed worldwide, including throughout most U.S. states, Puerto Rico, and multiple countries including Australia, Belgium, Canada, China, France, Germany, Mexico, South Korea, the Netherlands, Poland, Spain, Switzerland, Taiwan, and the United Kingdom.
The source document does not specify a remedy or action for affected consumers to take.
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: 30 Lot/code info: REF (RPN): HNB5.0-38-80-P-NS-RC1 REF (GPN): G11543 Lot Number: 9906464 UDI: (01)00827002115439(17)220801(10)9906464
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.