Known Identifiers & Locations
FEI Numbers
1000122362
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 (2)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0035-2011 |
Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride)
General hospital use
Reason: There is the potential for a dimensional issue in 6 ml syringe products, codes E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, S5, to cause leakage and.or loss of sterility
|
2010-09-02 |
Terminated
|
View Details
|
| Z-0044-2007 |
0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex.
Reason: The syringe manufacturer mixed a pre-printed heparin labeled flush syringe with the saline syringes.
|
2006-04-24 |
Terminated
|
View Details
|
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