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 those involving the carotid arteries. The recall affects five units with lot number NS9904739 and was prompted by the potential compromise of product sterility due to an undersealed chevron in the packaging pouches. The affected catheters were distributed worldwide, including throughout most U.S. states and territories, as well as multiple countries including Canada, China, France, Germany, Italy, South Korea, Mexico, the Netherlands, Poland, and the United Kingdom.
The record 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: 5 Lot/code info: REF (RPN): HNB5.0-38-70-P-NS-SHK1.0 REF (GPN): G27689 Lot Number: NS9904739 UDI: (01)00827002276895(17)220801(10)NS9904739
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.