Device product
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.
Z-0010-2013
Product summary
- Event
- Event 63136
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,032 units
- Official record key
device-enforcement:Z-0010-2013
Official wording
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.
Code information: Catalog # 165808, Lot # NGWA1111
Distribution pattern: Nationwide distribution: USA and Puerto Rico
Derived failure modes
-
Unknown
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.