FDA recall Z-0852-2022

Human Care USA, Inc. · Class II · device

Product

Hanger-Bar 2P 45cm

Reason for recall

The Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of a manufacturing issue (failure to apply Loctite adhesive). As a result of the set screw loosening, there is the potential for a fall hazard.

Distribution

U.S. Nationwide distribution in the states of CA, IL, LA, MA, NV, OH, OK, PA, TX, UT, VA, and WV.

Key facts

Status
Ongoing
Initiation date
2021-11-01
Report date
2022-04-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0852-2022