IVEA 500A Intended for Med-Surg patient care.

FDA device recall Z-0767-2017 · posted 2016-12-15 · Terminated

Recall details

Recalling firm

Firefly Medical, Inc.

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

FOX

Quantity affected

239

Distribution

Worldwide Distribution -- USA and Canada.

Date initiated

2016-11-01

Date posted

2016-12-15

Date terminated

2017-08-01

Location

Fort Collins, CO