Recall Z-0269-2019— OriGen Biomedical, Inc.
Class I · Terminated
Class I FDA medical device recall by OriGen Biomedical, Inc., initiated 2015-03-30, terminated 2024-03-01. It names one FDA 510(k) clearance: K113869. Product: REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.. Reason: Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage.
- Recalling firm
- OriGen Biomedical, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-03-30
- Terminated
- 2024-03-01
- 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
REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.
Reason for recall
Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage
Data sourced from openFDA. This site is unofficial and independent of the FDA.