Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00
Reported: February 9, 2022 Initiated: December 23, 2021 #Z-0551-2022
Product Description
Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00
Reason for Recall
Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 35 units
- Distribution
- US Nationwide distribution in the states of AZ, CA, MA, NJ, PA, SC, TX, WI.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00. Recalled by Olympus Corporation of the Americas. Units affected: 35 units.
Why was this product recalled? ▼
Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 9, 2022. Severity: Moderate. Recall number: Z-0551-2022.
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