CLASS II Device recall · Reported 24 Oct 2018 · FDA Enforcement Report
Reinforced Dual Lumen Cannula recalled by OriGen Biomedical
OriGen Biomedical is recalling Reinforced Dual Lumen Cannula, distributed nationwide in the US. The recall was initiated on 21 Aug 2018 and the FDA has classified it as Class II.
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-0182-2019
- FDA event ID
- 80930
- Recalling firm
- OriGen Biomedical, Austin, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Aug 2018
- FDA classified
- 18 Oct 2018
- Reported
- 24 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 21 Aug 2018 | Recall initiated by company | |
| 18 Oct 2018 | Classified by FDA | +58 days |
| 24 Oct 2018 | 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
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Product as listed by the FDA
Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is 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.
Where it was distributed
Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL, AR, MO, GA, LA, DC, OR, MN, SC, OK, AZ, UT, RI, SD, WA, PA, AL, MD, IL, HI; and countries (OUS) of: Argentina, Austria, Belgium, CANADA, Colombia, EU, Germany, India, Italy, Japan, Kingdom of Saudi Arabia, Netherlands, New Zealand, Poland, Qatar, Romania, South Africa, SWEDEN, Thailand, UK, United Arab Emirates, and VIETNAM.
Nationwide AlabamaArkansasArizonaCaliforniaConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth Carolina
Questions about this recall
Why was it recalled?
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Which lots are affected?
UDI: 00816203022103, Lot: N18431, N18431-1
Where was it sold?
Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL, AR, MO, GA, LA, DC, OR, MN, SC, OK, AZ, UT, RI, SD, WA, PA, AL, MD, IL, HI; and countries (OUS) of: Argentina, Austria, Belgium, CANADA, Colombia, EU, Germany, India, Italy, Japan, Kingdom of Saudi Arabia, Netherlands, New Zealand, Poland, Qatar, Romania, South Africa, SWEDEN, Thailand, UK, United Arab Emirates, and VIETNAM.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
5 other products · FDA event 80930This product is part of a recall event; the main page for the event is Reinforced Dual Lumen Cannula recalled by OriGen Biomedical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Reinforced Dual Lumen Cannula recalled by OriGen Biomedical | OriGen Biomedical | Other | Nationwide | |
| CLASS II | Reinforced Dual Lumen Cannula recalled by OriGen Biomedical | OriGen Biomedical | Other | Nationwide | |
| CLASS II | Reinforced Dual Lumen Cannula recalled by OriGen Biomedical | OriGen Biomedical | Other | Nationwide | |
| CLASS II | ECMO Reinforced Dual Lumen Cannula recalled by OriGen Biomedical | OriGen Biomedical | Other | Nationwide | |
| CLASS II | Reinforced Dual Lumen Cannula recalled by OriGen Biomedical | OriGen Biomedical | Other | Nationwide |
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 |