FDA Device recall Z-0102-2019
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
- FDA Device
- Class II
- terminated
- Published 2018-10-24
On 2018-10-24 the FDA classified a Class II recall of Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO by Origen Biomedical, citing the catheter failed the endotoxin testing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0102-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-21 |
| Published | 2018-10-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Origen Biomedical |
| Distribution | US |
Product
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
Reason
The catheter failed the endotoxin testing.
Identifiers
| code_info | UDI: 00816203022059, lot N18687-1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0102-2019%22
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