Reported Sep 14, 2022 · Ongoing
Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Balt USA, LLC
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: BALT USA, LLC · 29 Parker Ste 100 · Irvine, CA · 92618-1667
Is this the product you have?
- Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
- Lot codes and dates
- Model NumberOPTI0520CSF10
- UDI-DI Code00818053026164
- Lot NumberF220600470
- Amount recalled
- 4 devices
Where it was sold
Why it was recalled
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
This product could cause temporary or reversible health problems — stop using it.
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