CLASS I Device recall · Reported 29 Apr 2015 · FDA Enforcement Report
VV13F Reinforced Dual Lumen Catheter Sterile Disposable recalled
OriGen Biomedical is recalling VV13F Reinforced Dual Lumen Catheter Sterile Disposable: DO Not Re-use, distributed nationwide in the US. The recall was initiated on 30 Mar 2015 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1456-2015
- FDA event ID
- 70988
- Recalling firm
- OriGen Biomedical, Austin, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 30 Mar 2015
- FDA classified
- 23 Apr 2015
- Reported
- 29 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 30 Mar 2015 | Recall initiated by company | |
| 23 Apr 2015 | Classified by FDA | +24 days |
| 29 Apr 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution: US (nationwide) and countries of: Spain, UK, Germany, Sweden, and Netherlands.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot N18549
Where was it sold?
Worldwide Distribution: US (nationwide) and countries of: Spain, UK, Germany, Sweden, and Netherlands.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from OriGen Biomedical
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Accessory Sets Syringes: syringe with a female luer recalled | OriGen Biomedical | Packaging Defects | 11 states |
| Device | CLASS III | Evolve Cell Culture, part numbers: EV1000N recalled by OriGen Biomedical | OriGen Biomedical | Labeling Errors | 19 states |
| Device | CLASS II | 3/8" FloPump, (Sterile) recalled by OriGen Biomedical | OriGen Biomedical | Other | TX |
| Device | CLASS I | ECMO Reinforced Dual Lumen Cannula, Sterile EO recalled | OriGen Biomedical | Device Malfunction | 33 states |
| Device | CLASS I | ECMO Reinforced Dual Lumen Cannula, Sterile EO recalled | OriGen Biomedical | Device Malfunction | 33 states |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |