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 packaging pouches caused by an undersealed chevron. These catheters are intended for use by trained physicians in peripheral and coronary vascular procedures, including procedures involving the carotid arteries. The affected products have lot number 9707478 and a specific reference number (HNB5.0-38-100-P-NS-JR3.5), with a total of 10 units recalled.
The recalled catheters were distributed worldwide, including across numerous U.S. states and multiple countries including Australia, Canada, China, France, Germany, and the United Kingdom, among others. The source document does not specify what actions affected consumers should take in response to 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: 10 Lot/code info: REF (RPN): HNB5.0-38-100-P-NS-JR3.5 REF (GPN): G05928 Lot Number: 9707478 UDI: (01)00827002059283(17)220513(10)9707478
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.