Z-0480-2020 Class II Terminated
FDA device recall Z-0480-2020 was initiated by Cook Inc. on Oct 21, 2019 and is designated Class II. Reason for recall: The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. The recall status is terminated (terminated Jun 30, 2020). Affected quantity: 30.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 27, 2019
- Initiation Date
- Oct 21, 2019
- Termination Date
- Jun 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30
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): HNB5.0-38-80-P-NS-RC1 REF (GPN): G11543 Lot Number: 9906464 UDI: (01)00827002115439(17)220801(10)9906464
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0480-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026