Reported Jun 22, 2022 · Terminated
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Volcano Corp.
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: Volcano Corp · 3721 Valley Centre Dr Ste 500 · San Diego, CA · 92130-3328
Is this the product you have?
- Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
- Lot codes and dates
- Model Number89185J
- Part Number300000252891
- UDI Code(01)00845225003050(11)220309(17)250309(10)0302535768
- Serial Numbers
3758337586375903759837612376483765537692376943770937719
- Amount recalled
- 11 devices
Where it was sold
Why it was recalled
Due to a potential failed sterilization process.
This product could cause temporary or reversible health problems — stop using it.
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