IVEA Product Part Number 16100 Model 500A
FDA Recall Z-3239-2017 · Posted 2017-09-07
Recalling FirmFirefly Medical, Inc.
Recall StatusTerminated
Product CodeFOX
Date Initiated2017-08-24
Date Terminated2019-11-01
Product Quantity570 units
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
United States, Australia, Belgium, Canada, China, Germany, Hong Kong, Indonesia, Israel, Netherlands, Singapore, UAE
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.