IVEA Product Part Number 16100 Model 500A

FDA device recall Z-3239-2017 · posted 2017-09-07 · Terminated

Recall details

Recalling firm

Firefly Medical, Inc.

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.

Action taken

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

Status

Terminated

Product code

FOX

Quantity affected

570 units

Distribution

United States, Australia, Belgium, Canada, China, Germany, Hong Kong, Indonesia, Israel, Netherlands, Singapore, UAE

Date initiated

2017-08-24

Date posted

2017-09-07

Date terminated

2019-11-01

Location

Fort Collins, CO