FDA Medical Device Recalls (openFDA)
Firefly Medical, Inc.: IVEA 500A Intended for Med-Surg patient care.
- Recall number
- Z-0767-2017
- Recalling firm
- Firefly Medical, Inc.
- Product
- IVEA 500A Intended for Med-Surg patient care.
- Status
- Terminated
- Initiated
- 2016-11-01
- Posted
- 2016-12-15
- Terminated
- 2017-08-01
- 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.
- 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 info@iveamobility.com if they have any questions.
- Quantity
- 239
- Distribution
- Worldwide Distribution -- USA and Canada.
- Lot, serial or model codes
- Product Part Number 16100. Serial Numbers 100200-101068, except for serial numbers within this range not released into final inventory for other reasons.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FOX
- Firm FEI
- 3011390406
- Firm city
- Fort Collins
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28