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 recall affects 25 catheters with lot number 9936120 and specific product codes (HNB5.0-38-80-P-NS-MPB and G09631). These catheters were distributed worldwide, including across most U.S. states and multiple countries in Europe, Asia, Africa, and the Americas.
The catheters are being recalled because the chevron seal on their packaging pouches may be undersealed, which could compromise the sterility of the products. The source document does not specify what action 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: 25 Lot/code info: REF (RPN): HNB5.0-38-80-P-NS-MPB REF (GPN): G09631 Lot Number: 9936120 UDI: (01)00827002096318(17)220820(10)9936120
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.