FDA Device recall Z-0198-2016
Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
- FDA Device
- Class III
- terminated
- Published 2015-11-11
On 2015-11-11 the FDA classified a Class III recall of Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units by C R Bard, citing incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0198-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-10-02 |
| Published | 2015-11-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | C R Bard |
| Distribution | US |
Product
Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
Reason
Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French.
Identifiers
| code_info | Lot 53620131 |
|---|
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-0198-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.