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 00827002105997

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

What happened

Cook Inc. is recalling Torcon NB Advantage Catheters due to a 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 those involving the carotid arteries. The recall affects 35 units distributed worldwide, including across most U.S. states and multiple countries including Canada, China, France, Germany, South Korea, Mexico, the United Kingdom, and others.

The affected products have specific lot numbers (NS9903072, NS9904741, NS9914967, NS9928940, NS9933626, and NS9942737) with corresponding UDI codes. The source document does not specify what remedy or action affected 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: 35 Lot/code info: REF (RPN): HNB5.0-38-80-P-NS-HS1 REF (GPN): G10599 Lot Numbers: NS9903072, NS9904741, NS9914967, NS9928940, NS9933626, NS9942737 UDIs: (01)00827002105997(17)220731(10)NS9903072, (01)00827002105997(17)220801(10)NS9904741, (01)00827002105997(17)220805(10)NS9914967, (01)00827002105997(17)220809(10)NS9928940, (01)00827002105997(17)220816(10)NS9933626, (01)00827002105997(17)220826(10)NS9942737

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