Recall Z-1912-2015— Vascutek, Ltd.
Class II · Terminated
Class II FDA medical device recall by Vascutek, Ltd., initiated 2015-05-15, terminated 2015-10-20. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft..
- Recalling firm
- Vascutek, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-15
- Terminated
- 2015-10-20
- Firm location
- Inchinnan, United Kingdom
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.