Recall Z-0767-2017 ยท FOX Stand, Infusion
Firefly Medical, Inc.
IVEA 500A Intended for Med-Surg patient care.
| Date | Dec 15, 2016 (initiated Nov 1, 2016) |
| Status | Terminated |
| 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 n |
| Quantity | 239 |
| Distribution | Worldwide Distribution -- USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.