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 00827002107410

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

What happened

Cook Inc. is recalling 232 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 of sterility due to an undersealed chevron in the packaging pouches. The affected products were distributed worldwide and throughout the United States, with specific lot numbers identified: 9706696, 9707671, 9709328, 9711384, and 9718538.

The recall record does not specify a remedy or instructions for affected consumers on what action they 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: 232 Lot/code info: REF (RPN): HNB5.0-38-110-P-12S-PIG REF (GPN): G10741 Lot Numbers: 9706696, 9707671, 9709328, 9711384, 9718538 UDIs: (01)00827002107410(17)220513(10)9706696, (01)00827002107410(17)220514(10)9707671, (01)00827002107410(17)220515(10)9709328, (01)00827002107410(17)220515(10)9711384, (01)00827002107410(17)220516(10)9718538

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