Tenacore LLC
Tenacore LLC appears in FDA public data with 2 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1331-2021, Class I) was initiated on February 25, 2021.
Summary
- Total Recalls
- 2 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1331-2021 | Class I | Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair | February 25, 2021 |
| Z-1332-2021 | Class I | Alaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410 | February 25, 2021 |