FDA Device recall Z-0021-2018
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device
- FDA Device
- Class I
- terminated
- Published 2017-11-01
On 2017-11-01 the FDA classified a Class I recall of The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device by Origen Biomedical, citing two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has had a separation of the clear extension tube from the hub connection. These adverse e….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0021-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-08-02 |
| Published | 2017-11-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Origen Biomedical |
| Distribution | US |
Product
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
Reason
Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has had a separation of the clear extension tube from the hub connection. These adverse events resulted in patient injury (blood loss).
Identifiers
| code_info | Lot Numbers: N18487, N18487-1 |
|---|
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-0021-2018%22
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