The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of
FDA device recall Z-0021-2018 · posted 2017-10-20 · Terminated
Recall details
- Recalling firm
- OriGen Biomedical, Inc.
- 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).
- Action taken
- The firm initiated their recall by letter on 08/02/2017, following with a press release on 08/28/2017. The firm sent a revised letter to include instructions for the distributors on 09/22/2017 and an updated press release was sent on 09/26/2017. The firm requested that the consignee discontinue use of all OriGen VV28F Reinforced Dual Lumen ECMO Catheters from lots N18487 and N18487-1 and return any of those lots to OriGen Biomedical immediately for replacement or product credit.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 180 units
- Distribution
- US Nationwide and the countries of Austria, Belgium, Chile, Czech Republic, Italy, Kingdom of Saudi Arabia, Netherlands, Poland, Sweden, Thailand, Colombia, India, South Africa, United Arab Emirates.
- Date initiated
- 2017-08-02
- Date posted
- 2017-10-20
- Date terminated
- 2024-02-29
- Location
- Austin, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ORIGEN REINFORCED DUAL LUMEN CATHETER (K113869) | Origen Biomedical, Inc. | 2012-07-26 |