Olympus Corporation of the Americas Recall 89333
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
Olympus Corporation of the Americas Recall 89333 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0551-2022 |
| Event ID | 89333 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AZ, CA, MA, NJ, PA, SC, TX, WI. |
| Quantity | 35 units |
| Recall Reason | Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm) |
| Device Classification | 20220209 |
| Device Code Info | Lot Number: WS147887-01 UDI: 896506002309 Expiration Date: 4/30/2024 |
| Center Classification Date | 20220201 |
| Recall Initiation Date | 20211223 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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