Recall Z-0021-2018— OriGen Biomedical, Inc.
Class I · Terminated
Class I FDA medical device recall by OriGen Biomedical, Inc., initiated 2017-08-02, terminated 2024-02-29. It names one FDA 510(k) clearance: K113869. 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)..
- Recalling firm
- OriGen Biomedical, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2017-08-02
- Terminated
- 2024-02-29
- Firm location
- Austin, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.