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 195 Torcon NB Advantage Catheters due to potential compromise of sterility caused by undersealed chevrons in the packaging pouches. These catheters are intended for use by trained physicians in peripheral and coronary vascular system procedures, including procedures involving the carotid arteries. The affected products were distributed worldwide, including throughout most U.S. states and multiple countries including Australia, Canada, China, France, Germany, Mexico, South Korea, and the United Kingdom.
The recalled catheters are identified by specific lot numbers (9712521, 9732872, and NS9717350) and corresponding UDIs. The source document 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: 195 Lot/code info: REF (RPN): HNB5.0-38-100-P-NS-JL3 REF (GPN): G10998 Lot Numbers: 9712521, 9732872, NS9717350 UDIs: (01)00827002109988(17)220516(10)9712521, (01)00827002109988(17)220517(10)9732872, (01)00827002109988(17)220517(10)NS9717350
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.