Device product
Gelseal Straight Diameter 8mm Length 15cm. 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.
Z-1912-2015
Product summary
- Firm
- Vascutek, Ltd.
- Event
- Event 71305
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12
- Official record key
device-enforcement:Z-1912-2015
Official wording
Reason: Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Code information: Product Code 431508, Batch 301509/01, Serial Numbers 0001515180, 0001515181, 0001515182, 0001515183, 0001515184, 0001515185, 0001515186, 0001515187, 0001515188, 0001515189, 0001515190, 0001515191
Distribution pattern: Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
Derived failure modes
-
Unknown
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.