FDA Device recall Z-1913-2015
Gelseal Straight Diameter 8mm Length 30cm
- FDA Device
- Class II
- terminated
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of Gelseal Straight Diameter 8mm Length 30cm by Vascutek, citing product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1913-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-15 |
| Published | 2015-07-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Vascutek |
| Distribution | MI |
Product
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
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Identifiers
| code_info | Product Code 433008, Batch 301509/02, Serial Numbers 0001515204, 0001515205, 0001515206, 0001515207, 0001515208, 000151…Product Code 433008, Batch 301509/02, Serial Numbers 0001515204, 0001515205, 0001515206, 0001515207, 0001515208, 0001515209, 0001515210, 0001515211, 0001515212, 0001515213, 0001515214, 0001515215 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1913-2015%22
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