8 Fr — Class II medical device recall Z-0010-2013
Terminated recall by C.R. Bard, Inc., Urological Division, reported 2012-10-10, distributed nationwide. The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (10 ml instead
| Recall number | Z-0010-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard, Inc., Urological Division, Covington, GA, United States |
| Recall initiated | 2012-09-07 |
| Classified | 2012-10-04 |
| Reported by FDA | 2012-10-10 |
| Terminated | 2013-03-21 |
| Distributed | Nationwide (US) |
| Quantity | 4,032 units |
| Lot numbers | NGWA1111 |
| Model numbers | 165808 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0010-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.