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 80 Torcon NB Advantage Catheters used by physicians in peripheral and coronary vascular procedures, including procedures involving the carotid arteries. The catheters are affected by potentially undersealed chevrons in their packaging pouches, which could compromise the sterility of the products. The recall affects products distributed nationwide across most U.S. states and Puerto Rico, as well as internationally to countries including Canada, France, Germany, the United Kingdom, Japan, South Korea, Mexico, and others.
The affected catheters have reference number HNB7.0-38-65-P-NS-VERT and lot numbers NS9880363, NS9890272, and NS9933625. 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: 80 Lot/code info: REF (RPN): HNB7.0-38-65-P-NS-VERT REF (GPN): G05018 Lot Numbers: NS9880363, NS9890272, NS9933625 UDIs: (01)00827002050181(17)220731(10)NS9880363, (01)00827002050181(17)220805(10)NS9890272, (01)00827002050181(17)220812(10)NS9933625
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.