Recall Z-0852-2022— Human Care USA, Inc.
Class II · Ongoing
Class II FDA medical device recall by Human Care USA, Inc., initiated 2021-11-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Hanger-Bar 2P 45cm. 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..
- Recalling firm
- Human Care USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-11-01
- Firm location
- Austin, TX, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.