Cook Inc.: 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 traine

Is my product affected?

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.

• UPC 00827002060746

Check against the official notice below — it lists the full affected range.

What happened

Cook Inc. is recalling 740 units of Torcon NB Advantage Catheters used by physicians in peripheral and coronary vascular procedures, including procedures involving the carotid arteries. The catheters are being recalled because of a potential compromise to product sterility caused by an undersealed chevron in the packaging pouches.

The affected catheters were distributed worldwide and throughout most U.S. states, as well as in multiple countries including Canada, the United Kingdom, Australia, and Mexico. The recall involves ten specific lot numbers (9696580, 9707470, 9707471, 9710400, 9710402, 9710403, 9710404, 9710405, 9734099, and NS9710401). The source document does not specify a remedy or recommended action for consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Details from the source

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: 740 Lot/code info: REF (RPN): HNB5.0-38-100-P-NS-VERT REF (GPN): G06074 Lot Numbers: 9696580, 9707470, 9707471, 9710400, 9710402, 9710403, 9710404, 9710405, 9734099, NS9710401 UDIs: (01)00827002060746(17)220508(10)9696580, (01)00827002060746(17)220513(10)9707470, (01)00827002060746(17)220514(10)9707471, (01)00827002060746(17)220515(10)9710400, (01)00827002060746(17)220516(10)9710402, (01)00827002060746(17)220515(10)9710403, (01)00827002060746(17)220515(10)9710404, (01)00827002060746(17)220514(10)9710405, (01)00827002060746(17)220524(10)9734099, (01)00827002060746(17)220513(10)NS9710401

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 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.2019-10-21
• 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.2019-10-21
• 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.2019-10-21
• 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.2019-10-21
• 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.2019-10-21

All FDA (Device enforcement) recalls