FDA Device recall Z-1358-2016
BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter
- 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 5cc Foley Catheter 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-1358-2016 |
| 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 5cc Foley Catheter. 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 | Code(s): Catalog numbers: 01655SI12, 01655SI14, 01655SI16, 01655SI18, 01655SI20, 01655SI22, 01655SI24, 01655SI26, 01655…Code(s): Catalog numbers: 01655SI12, 01655SI14, 01655SI16, 01655SI18, 01655SI20, 01655SI22, 01655SI24, 01655SI26, 01655SI28 and 01655SI30. 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-1358-2016%22
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