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 95 Torcon NB Advantage Catheters due to potential compromised 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 lot number 9729997 and was distributed worldwide, including throughout most U.S. states and multiple countries.
The recall affects catheters with reference number HNB5.0-38-100-P-NS-C2 and GPN G10262. The source document does not specify a remedy or recommended action for affected consumers.
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: 95 Lot/code info: REF (RPN): HNB5.0-38-100-P-NS-C2 REF (GPN): G10262 Lot Number: 9729997 UDI: (01)00827002102620(17)220516(10)9729997
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.