Antibacterial Hydro Personal Catheter — Class III medical device recall Z-0198-2016
Terminated recall by C.R. Bard, Inc., reported 2015-11-11, distributed nationwide. Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 Fre
| Recall number | Z-0198-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard, Inc., Covington, GA, United States |
| Recall initiated | 2015-10-02 |
| Classified | 2015-11-02 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2016-08-01 |
| Distributed | Nationwide (US) |
| Quantity | 4,170 units |
| Reason classes | labeling |
| Lot numbers | 53620131 |
Product
Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
Reason for recall
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.
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-0198-2016. 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.