Recall Z-1456-2015— OriGen Biomedical, Inc.
Class I · Terminated
Class I FDA medical device recall by OriGen Biomedical, Inc., initiated 2015-03-30, terminated 2016-05-03. It names one FDA 510(k) clearance: K113869. Product: OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a single cannula for both venous drainage and 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
- 2016-05-03
- 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
OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a single cannula for both venous drainage and 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.