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 00827002059245

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

What happened

Cook Inc. is recalling 585 Torcon NB Advantage Catheters due to potential compromise of product 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 the carotid arteries. The affected products were distributed worldwide, including throughout most U.S. states and territories, as well as countries in Europe, Asia, the Middle East, Africa, and the Americas.

The recall affects seven specific lot numbers: 9705826, 9707669, 9709326, 9714955, 9716791, 9717961, and NS9718543. Affected products are identified by reference number HNB5.0-38-100-P-NS-JL3.5 and GPN G05924. The source document does not specify a remedy or actions that consumers should take.

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: 585 Lot/code info: REF (RPN): HNB5.0-38-100-P-NS-JL3.5 REF (GPN): G05924 Lot Numbers: 9705826, 9707669, 9709326, 9714955, 9716791, 9717961, NS9718543 UDIs: (01)00827002059245(17)220516(10)9705826, (01)00827002059245(17)220513(10)9707669, (01)00827002059245(17)220515(10)9709326, (01)00827002059245(17)220516(10)9714955, (01)00827002059245(17)220510(10)9716791, (01)00827002059245(17)220511(10)9717961, (01)00827002059245(17)220516(10)NS9718543

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