Wellspect HealthCare (Division of DENTSPLY IH AB)
Wellspect HealthCare (Division of DENTSPLY IH AB) appears in FDA public data with 3 recalls, 0 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2644-2020, Class II) was initiated on June 17, 2020.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 0
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2644-2020 | Class II | LoFric Origo, Tiemann, 16in, FR12 urinary catheters | June 17, 2020 |
| Z-2643-2020 | Class II | LoFric Origo, Nelaton, 16in, FR10 urinary catheters | June 17, 2020 |
| Z-2645-2020 | Class II | LoFric Origo, Tiemann, 16in, FR14 urinary catheters | June 17, 2020 |