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Firefly Medical, Inc. recalls IVEA Product Part Number 16100 Model 500A
Recalled October 11, 2017 · FDA recall Z-3239-2017 · Firefly Medical
Hazard
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. · FDA Class II
Units
570 units
Sold at
United States, Australia, Belgium, Canada, China, Germany, Hong Kong, Indonesia, Israel, Netherlands, Singapore, UAE
Description
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.
Product
IVEA Product Part Number 16100 Model 500A
Manufacturer(s)
Firefly Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →