CLASS I Device recall · Reported 12 Jun 2019 · FDA Enforcement Report
ECMO Reinforced Dual Lumen Cannula, Sterile EO recalled
OriGen Biomedical is recalling ECMO Reinforced Dual Lumen Cannula, Sterile EO, distributed in 33 states. The recall was initiated on 17 Jan 2017 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-1230-2019
- FDA event ID
- 82512
- Recalling firm
- OriGen Biomedical, Austin, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 17 Jan 2017
- FDA classified
- 4 Jun 2019
- Reported
- 12 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Heart & Vascular Devices
Timeline
| 17 Jan 2017 | Recall initiated by company | |
| 4 Jun 2019 | Classified by FDA | +868 days |
| 12 Jun 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F
Where it was distributed
US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT, RI, NJ, SD, PA, MS, NM. Foreign (OUS): UAE, Saudi Arabia, Colombia, UK, Netherlands, Italy, Czech Republic, Germany, India, Japan, Canada, Thailand, Sweden, Belgium, Spain, Poland, South Africa, Chile
AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIllinoisIndianaKentuckyLouisianaMassachusettsMichiganMinnesotaMissouriMississippiNorth CarolinaNew Jersey
Questions about this recall
Is ECMO Reinforced Dual Lumen Cannula, Sterile EO recalled?
Yes. OriGen Biomedical recalled ECMO Reinforced Dual Lumen Cannula, Sterile EO on 17 Jan 2017. The recall is Class I and its status is Terminated. Recall number Z-1230-2019.
Why was it recalled?
Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
Which lots are affected?
Lots: N18573, N18687-1
Where was it sold?
US: NY, AB, AR, FL, MO, NC, GA, LA, CO, AL, MA, CA, MI, WI, TX, DC, OH, CT, TN, IN, OR, IL, MN, QC, SC, KY, OK, AZ, UT, RI, NJ, SD, PA, MS, NM. Foreign (OUS): UAE, Saudi Arabia, Colombia, UK, Netherlands, Italy, Czech Republic, Germany, India, Japan, Canada, Thailand, Sweden, Belgium, Spain, Poland, South Africa, Chile
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 21 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 | Sterility | 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 | Sterility | TX |
| Device | CLASS I | ECMO Reinforced Dual Lumen Cannula, Sterile EO recalled | OriGen Biomedical | Lead & Heavy Metals | 33 states |
| Device | CLASS I | ECMO Reinforced Dual Lumen Cannula, Sterile EO recalled | OriGen Biomedical | Lead & Heavy Metals | 33 states |
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