FDA Device recall Z-1357-2016
BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only
- FDA Device
- Class II
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class II recall of BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only by C R Bard, citing labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1357-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-18 |
| Published | 2016-04-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | C R Bard |
| Distribution | US |
Product
BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
Reason
Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
Identifiers
| code_info | Catalog numbers: 0165I108 and 065SI10; All lot numbers produced with IFU (PK7634040) are affected. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1357-2016%22
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