Recall Z-0851-2022 ยท FSA Lift, Patient, Non-Ac-Powered
Human Care USA, Inc.
Hanger-Bar 2P 45cm
| Date | Nov 1, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | On 11/01/2021, the firm emailed an "URGENT PRODUCT CORRECTION" Notification to customers/distributors informing them that Loctite may be missing on the stop-screw which holds the hanger-bar hook in place. This is the hook which connects to the distance strap. Because there is a possibility of the screw coming loose from the hook in that case the user may fall. If the user falls there is a risk of minor to more serious injury. This depends on the fall level, the surface user falls on and the strength and state of health of the user. Customers are instructed to: 1. Unscrew the M4 screw (fig |
| Quantity | 10 devices |
| Distribution | U.S. Nationwide distribution in the states of CA, IL, LA, MA, NV, OH, OK, PA, TX, UT, VA, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.