Known Identifiers & Locations
FEI Numbers
1000116158
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (1)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0003-2022 |
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Reason: There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
|
2021-09-13 |
Open, Classified
|
View Details
|
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