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.
Reported: July 8, 2015 Initiated: May 15, 2015 #Z-1912-2015
Product Description
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.
Reason for Recall
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Details
- Recalling Firm
- Vascutek, Ltd.
- Units Affected
- 12
- Distribution
- Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
- Location
- Inchinnan
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Vascutek, Ltd.. Units affected: 12.
Why was this product recalled? ▼
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 8, 2015. Severity: Moderate. Recall number: Z-1912-2015.
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