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U.S. Department of Health and Human Services

Class 2 Device Recall IVEA

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 Class 2 Device Recall IVEAsee related information
Date Initiated by FirmNovember 01, 2016
Date PostedDecember 15, 2016
Recall Status1 Terminated 3 on August 01, 2017
Recall NumberZ-0767-2017
Recall Event ID 75571
Product Classification Stand, infusion - Product Code FOX
ProductIVEA 500A Intended for Med-Surg patient care.
Code Information Product Part Number 16100. Serial Numbers 100200-101068, except for serial numbers within this range not released into final inventory for other reasons.
FEI Number 3011390406
Recalling Firm/
Manufacturer		 Firefly Medical, Inc.
320 E Vine Dr Ste 312
Fort Collins CO 80524-2332
For Additional Information ContactTrevor Carlton
970-472-5323
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionFirm 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 in Commerce239
DistributionWorldwide Distribution -- USA and Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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