Austin, TX, United States
Human Care USA, Inc. recalls
1 recall recorded since 2018, most recently on 1 November 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 1 November 2021
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0852-2022, Z-0851-2022
- Hanger-Bar 2P 45cm
- Hanger-Bar 2P 45cm
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.