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 00827002062825

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

What happened

Cook Inc. is recalling Torcon NB Advantage Catheters used by physicians in blood vessel procedures, including those involving the heart and neck arteries. The catheters are being recalled because the packaging pouches may have an undersealed chevron (a sealing point), which could allow the sterile product inside to become contaminated. A total of 16 units with six specific lot numbers have been affected and distributed worldwide, including across most U.S. states, Puerto Rico, and multiple countries.

The recall notice does not specify what consumers or patients should do in response to this recall.

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: 16 Lot/code info: REF (RPN): HNB5.0-35-80-P-NS-MPB REF (GPN): G06282 Lot Numbers: NS9904055, NS9913496, NS9928938, NS9930289, NS9930290, NS9930291 UDIs: (01)00827002062825(17)220731(10)NS9904055, (01)00827002062825(17)220805(10)NS9913496, (01)00827002062825(17)220812(10)NS9928938, (01)00827002062825(17)220809(10)NS9930289, (01)00827002062825(17)220809(10)NS9930290, (01)00827002062825(17)220812(10)NS9930291

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