Z-1913-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2015
- Initiation Date
- May 15, 2015
- Termination Date
- October 20, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12
Product Description
Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
Reason for Recall
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Distribution Pattern
Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
Code Information
Product Code 433008, Batch 301509/02, Serial Numbers 0001515204, 0001515205, 0001515206, 0001515207, 0001515208, 0001515209, 0001515210, 0001515211, 0001515212, 0001515213, 0001515214, 0001515215