Reported Jun 12, 2019 · Terminated
ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F
OriGen Biomedical, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: OriGen Biomedical, Inc. · 7000 Burleson Rd Bldg D · Austin, TX · 78744-3202
Is this the product you have?
- ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only
- REFVV13F
- Lot codes and dates
- Lots
N18573N18687-1
- Lots
- Amount recalled
- 145
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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