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Terminated

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.

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