FDA Device recall Z-0767-2017
IVEA 500A Intended for Med-Surg patient care
- FDA Device
- Class II
- terminated
- Published 2016-12-21
On 2016-12-21 the FDA classified a Class II recall of IVEA 500A Intended for Med-Surg patient care by Firefly Medical, citing the dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0767-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-01 |
| Published | 2016-12-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Firefly Medical |
| Distribution | n/a |
Product
IVEA 500A Intended for Med-Surg patient care.
Reason
The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.
Identifiers
| code_info | Product Part Number 16100. Serial Numbers 100200-101068, except for serial numbers within this range not released into final inventory for other reasons. |
|---|
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-0767-2017%22
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