Reported Oct 24, 2018 · Terminated
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF:…
OriGen Biomedical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- Reinforced Dual Lumen Cannula, 13Fr
- REFVV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr
- REFVV13F, Sterile EO
- Lot codes and dates
- UDI
00816203022059lot N18687-1
- UDI
- Amount recalled
- 106
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
The catheter failed the endotoxin testing.
This product could cause temporary or reversible health problems — stop using it.
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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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