FDA Device recall Z-0010-2013
8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon
- FDA Device
- Class II
- terminated
- Published 2012-10-10
On 2012-10-10 the FDA classified a Class II recall of 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon by C R Bard Urological Division, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0010-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-07 |
| Published | 2012-10-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | C R Bard Urological Division |
| Distribution | US |
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.
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.
Identifiers
| code_info | Catalog # 165808, Lot # NGWA1111 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0010-2013%22
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