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 used by physicians in peripheral and coronary vascular procedures, including procedures involving the carotid arteries. The catheters are being recalled due to potentially compromised sterility caused by undersealed chevrons in the packaging pouches. A total of 425 units across ten lot numbers have been affected, with worldwide distribution including all U.S. states and Puerto Rico, as well as distribution in Australia, Belgium, Canada, China, the Czech Republic, Denmark, France, Germany, Guatemala, Hong Kong, Italy, South Korea, Luxembourg, Mexico, the Netherlands, Pakistan, Poland, South Africa, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
The affected lot numbers are 9694590, 9700380, 9700381, 9700765, 9703643, 9703644, 9703645, 9703646, 9711281, and 9711282. The product reference number is HNB5.0-38-100-P-10S-PIG. The recall source does not specify what action 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: 425 Lot/code info: REF (RPN): HNB5.0-38-100-P-10S-PIG REF (GPN): G06227 Lot Numbers: 9694590, 9700380, 9700381, 9700765, 9703643, 9703644, 9703645, 9703646, 9711281, 9711282 UDIs: (01)00827002062276(17)220508(10)9694590, (01)00827002062276(17)220510(10)9700380, (01)00827002062276(17)220508(10)9700381, (01)00827002062276(17)220509(10)9700765, (01)00827002062276(17)220513(10)9703643, (01)00827002062276(17)220513(10)9703644, (01)00827002062276(17)220510(10)9703645, (01)00827002062276(17)220510(10)9703646, (01)00827002062276(17)220515(10)9711281, (01)00827002062276(17)220516(10)9711282
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.