MINISCAV (tm) Vacuum Pump
FDA device recall Z-2619-2023 · posted 2023-09-20 · Open, Classified
Recall details
- Recalling firm
- R A Medical Services
- Reason for recall
- Inadequate documentation of acceptance activity
- Action taken
- R A Medical Services notified the only consignee via email on 08/23/2023. Instructions were to quarantine and return affected units.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- BTA
- Quantity affected
- 10 units
- Distribution
- Distribution to Ohio
- Date initiated
- 2023-08-23
- Date posted
- 2023-09-20
- Location
- Keighley, United Kingdom
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MINISCAV (K160950) | Sedation Systems, LLC | 2017-05-05 |