CLASS II ONGOING Device recall · Reported 6 Apr 2022 · FDA Enforcement Report
Hanger-Bar 2P recalled by Human Care USA
Human Care USA is recalling Hanger-Bar 2P, distributed nationwide in the US. The recall was initiated on 1 Nov 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0851-2022
- FDA event ID
- 89509
- Recalling firm
- Human Care USA, Austin, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Nov 2021
- FDA classified
- 31 Mar 2022
- Reported
- 6 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 1 Nov 2021 | Recall initiated by company | |
| 31 Mar 2022 | Classified by FDA | +150 days |
| 6 Apr 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Hanger-Bar 2P 45cm
Where it was distributed
U.S. Nationwide distribution in the states of CA, IL, LA, MA, NV, OH, OK, PA, TX, UT, VA, and WV.
Nationwide CaliforniaIllinoisLouisianaMassachusettsNevadaOhioOklahomaPennsylvaniaTexasUtahVirginiaWest Virginia
Questions about this recall
Is Hanger-Bar 2P recalled?
Yes. Human Care USA recalled Hanger-Bar 2P on 1 Nov 2021. The recall is Class II and its status is Ongoing. Recall number Z-0851-2022.
Why was it recalled?
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.
Which lots are affected?
Part Number 72754 UPC Code: 881608800397 EAN Code: 7331599999707 Lot Number: 33218501
Where was it sold?
U.S. Nationwide distribution in the states of CA, IL, LA, MA, NV, OH, OK, PA, TX, UT, VA, and WV.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Human Care USA
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hanger-Bar 2P recalled by Human Care USA | Human Care USA | Device Malfunction | Nationwide |
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