Mallinckrodt Manufacturing LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 2 (1 Class I)
- 510(k) Clearances
- 4
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2450-2023 | Class I | Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used | August 8, 2023 |
| Z-2687-2017 | Class II | Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Sto | October 17, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K242578 | EVOLVE Nitric Oxide Delivery System | January 3, 2025 |
| K222930 | Evolve Nitric Oxide Delivery System | December 6, 2023 |
| K211153 | Inomax DSIR | April 20, 2023 |
| K200389 | INOmax DSIR Plus | June 17, 2020 |