Known Identifiers & Locations
FEI Numbers
1018233
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-0010-2013 |
8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Reason: The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (10 ml instead of 5 ml) printed on the valve cap.
|
2012-09-07 |
Terminated
|
View Details
|
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