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 00827002070998

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 sterility in the product packaging. The catheters are intended for use by trained physicians in peripheral and coronary vascular procedures, including procedures involving the carotid arteries. The issue stems from an undersealed chevron in the packaging pouches. A total of 85 units were affected, distributed worldwide including across numerous U.S. states and multiple countries.

The recalled product has the reference number HNB5.0-38-100-P-NS-WNBG (RPN) and G07099 (GPN), with lot number 9716520 and UDI (01)00827002070998(17)220517(10)9716520. The source document does not specify what action affected consumers should take 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: 85 Lot/code info: REF (RPN): HNB5.0-38-100-P-NS-WNBG REF (GPN): G07099 Lot Number: 9716520 UDI: (01)00827002070998(17)220517(10)9716520

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