Z-1593-2021 Class II Terminated
FDA device recall Z-1593-2021 was initiated by W.L. Gore & Associates, Inc. on April 5, 2021 and is designated Class II. Reason for recall: The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length. The recall status is terminated (terminated January 16, 2024). Affected quantity: 61 devices.
Recall Details
- Product Type
- Devices
- Report Date
- May 26, 2021
- Initiation Date
- April 5, 2021
- Termination Date
- January 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 61 devices
Product Description
GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree.
Reason for Recall
The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, HI, IL, KS, MD, MN, NE, NY, OK, RI, TX, VA and the countries of Portugal, Italy.
Code Information
Serial Number: 22552467, 22552468, 22552469, 22552470, 22552471, 22552472, 22552473, 22552474, 22552475, 22552476, 22552477, 22552478, 22552479, 22552480, 22552481, 22552482, 22552483, 22552484, 22552756, 22552757, 22552758, 22552759, 22552760, 22552761, 22552762, 22552763, 22552764, 22552765, 22552766, 22552767, 22552768, 22552769, 22552770, 22552771, 22552772, 22552773, 22552774, 22552775, 22552776, 22552777, 22552778, 22552779, 22552780, 22552781, 22552782, 22613929, 22613930, 22613931