Z-3239-2017Class II

IVEA Product Part Number 16100 Model 500A

Name: Z-3239-2017 IVEA Product Part Number 16100 Model 500A
Creator: Firefly Medical, Inc.
Published: 2017-08-24
License: https://open.fda.gov/license/

Firefly Medical, Inc. / initiated 2017-08-24 / Terminated / root cause: design

FDA source

Firefly Medical, Inc. began a recall of IVEA Product Part Number 16100 Model 500A on 2017-08-24. FDA classified it as Class II and gives the reason as "The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3239-2017
Classification: Class II
Status: Terminated
Initiated: 2017-08-24
Posted: 2017-09-07
Terminated: 2019-11-01
Recalling firm: Firefly Medical, Inc.
Product: IVEA Product Part Number 16100 Model 500A
Product code: FOX Stand, Infusion
Reason for recall: The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit.
Root cause tag: design
FDA root cause: Device Design
Action: The recall notification is expected to begin on or before 9/8/17 after pin cap components are received for the corrections. Instructions in the recall notification letter do not include return of recall product. They are to be corrected in the field. If any units are returned, they will be labeled and quarantined until corrected by Firefly Medical personnel or the sub-contracted manufacturer supplier. The recall notification letter will be sent certified letter with return receipt.
Quantity in commerce: 570 units
Distribution: United States, Australia, Belgium, Canada, China, Germany, Hong Kong, Indonesia, Israel, Netherlands, Singapore, UAE
Product codes and lots: Serial Numbers - 100201, 100251, 100297, 100343, 100390, 100438, 100487, 100666, 100586, 100202, 100252, 100298, 100344, 100391, 100439, 100488, 100667, 100587, 100204, 100253, 100299, 100345, 100392, 100440, 100489, 100507, 100588, 100205, 100254, 100300, 100346, 100393, 100441, 100490, 100508, 100592, 100206, 100255, 100301, 100347, 100394, 100442, 100491, 100509, 100593, 100207, 100256, 100302, 100348, 100395, 100443, 100492, 100510, 100594, 100208, 100257, 100303, 100349, 100396, 100444, 100493, 100511, 100597, 100209, 100258, 100304, 100350, 100397, 100445, 100615, 100512, 100598, 100210, 100259, 100305, 100351, 100398, 100446, 100616, 100513, 100599, 100211, 100260, 100306, 100352, 100399, 100447, 100617, 100515, 100600, 100212, 100261, 100307, 100353, 100401, 100448, 100618, 100516, 100601, 100213, 100262, 100308, 100354, 100402, 100449, 100620, 100520, 100602, 100214, 100263, 100309, 100356, 100403, 100450, 100623, 100522, 100605, 100215, 100264, 100310, 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3239-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3239-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-11	2017-09-29

Product code FOX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)