FDA recall Z-3239-2017

Product

IVEA Product Part Number 16100 Model 500A

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-08-24

Report date

2017-10-11

Termination date

2019-11-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fort Collins, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3239-2017