Recall Z-0551-2022 ยท NJK Valve, Pulmonary
Olympus Corporation of the Americas
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
| Date | Dec 23, 2021 |
| Status | Open, Classified |
| Reason | Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm) |
| Root cause | Labeling Change Control |
| Action | Gyrus ACMI Inc. (Olympus) issued Urgent Medical Device Correction Letter dated 12/23/21. Letter states reason for recall, health risk and action to take: Inspect your inventory for the referenced device and identify any devices with the model number and lot number specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. Please contact Customer Service 1-888-524-7266, option 1, to obtain a Return Material Authorization. Olympus will issue a credit or replacement to your facility for your affected product. 2. Review your facility s use of |
| Quantity | 35 units |
| Distribution | US Nationwide distribution in the states of AZ, CA, MA, NJ, PA, SC, TX, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.