Z-0448-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2019
- Initiation Date
- October 21, 2019
- Termination Date
- June 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 311
Product Description
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.
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 Pattern
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.
Code Information
REF (RPN): HNB5.0-38-100-P-10S-0 REF (GPN): G07268 Lot Numbers: 9693491, 9696896, 9700377, 9700378, 9700379, 9710398, 9716496, NS9712994 UDIs: (01)00827002072688(17)220508(10)9693491, (01)00827002072688(17)220508(10)9696896, (01)00827002072688(17)220508(10)9700377, (01)00827002072688(17)220509(10)9700378, (01)00827002072688(17)220510(10)9700379, (01)00827002072688(17)220515(10)9710398, (01)00827002072688(17)220517(10)9716496, (01)00827002072688(17)220516(10)NS9712994