IVEA 500A Intended for Med-Surg patient care.
Recall
- Recall Number
- Z-0767-2017
- Event Number
- 75571
- Firm
- Firefly Medical, Inc.
- FEI Number
- 3011390406
- Product Code
- FOX
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- November 1, 2016
- Posted
- December 15, 2016
- Terminated
- August 1, 2017
- Address
- 320 E Vine Dr, Ste 312, Fort Collins, CO, 80524-2332
Description
IVEA 500A Intended for Med-Surg patient care.
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 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.
Worldwide Distribution -- USA and Canada.
239