IVEA 500A Intended for Med-Surg patient care.
FDA Recall Z-0767-2017 · Posted 2016-12-15
Recalling FirmFirefly Medical, Inc.
Recall StatusTerminated
Product CodeFOX
Date Initiated2016-11-01
Date Terminated2017-08-01
Product Quantity239
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- USA and Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.