Known Identifiers & Locations
FEI Numbers
1713683
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-0032-2007 |
Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy.
Reason: A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal.
|
2006-05-16 |
Terminated
|
View Details
|
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