Galemed Corporation
Galemed Corporation appears in FDA public data with 3 recalls — including 3 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0021-2020, Class I) was initiated on May 30, 2019.
Summary
- Total Recalls
- 3 (3 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0021-2020 | Class I | Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 247108 | May 30, 2019 |
| Z-0022-2020 | Class I | Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691 | May 30, 2019 |
| Z-0020-2020 | Class I | Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562 | May 30, 2019 |