Z-0767-2017Class II

IVEA 500A Intended for Med-Surg patient care

Name: Z-0767-2017 IVEA 500A Intended for Med-Surg patient care
Creator: Firefly Medical, Inc.
Published: 2016-11-01
License: https://open.fda.gov/license/

Firefly Medical, Inc. / initiated 2016-11-01 / Terminated / root cause: manufacturing process

FDA source

Firefly Medical, Inc. began a recall of IVEA 500A Intended for Med-Surg patient care on 2016-11-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0767-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-01
Posted: 2016-12-15
Terminated: 2017-08-01
Recalling firm: Firefly Medical, Inc.
Product: IVEA 500A Intended for Med-Surg patient care.
Product code: FOX Stand, Infusion
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Firm notified customers on **11/18/16** via certified "Urgent: Medical Device Recall (Field Correction) IVEA Model 500A" letter to correct product in the field. Customers were asked to thoroughly read the letter and to immediately follow the actions in the enclosed Product Correction Kit. The instructions include steps for cleaning the correction area and installing the permanent adhesive caps, as well as, completing and returning the product correction form to Firefly Medical. Customers may continue to use their units until the Product Correction actions are complete, as long as pins are not protruding. If the pins are protruding, then customers are to stop using the device immediately and complete the product correction instructions. Customers can call 970-472-5323 or e-mail [email protected] if they have any questions.
Quantity in commerce: 239
Distribution: Worldwide Distribution -- USA and Canada.
Product codes and lots: Product Part Number 16100. Serial Numbers 100200-101068, except for serial numbers within this range not released into final inventory for other reasons.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0767-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0767-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-15

Product code FOX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)