Reported Feb 9, 2022 · Ongoing
Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with…
Olympus Corporation of the Americas
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: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of
- breath and hyperinflation Model NumberSVS-V9-00
- Lot codes and dates
- Lot NumberWS147887-01
- UDI896506002309
- Expiration Date4/30/2024
- Amount recalled
- 35 units
Where it was sold
Why it was recalled
Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
This product could cause temporary or reversible health problems — stop using it.
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