CLASS II Device recall · Reported 4 Feb 2015 · FDA Enforcement Report
Assy, Power Supply 130v 50hz recalled by Fresenius Medical Care
Fresenius Medical Care Holdings is recalling Assy, Power Supply 130v 50hz, distributed in Florida, Oklahoma. The recall was initiated on 16 Dec 2014 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-1015-2015
- FDA event ID
- 70027
- Recalling firm
- Fresenius Medical Care Holdings, Waltham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Dec 2014
- FDA classified
- 27 Jan 2015
- Reported
- 4 Feb 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 16 Dec 2014 | Recall initiated by company | |
| 27 Jan 2015 | Classified by FDA | +42 days |
| 4 Feb 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Unqualified power assemblies shipped to customers.
Product as listed by the FDA
ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System
Where it was distributed
Distributed in OK and FL.
Questions about this recall
Why was it recalled?
Unqualified power assemblies shipped to customers.
Which lots are affected?
4P¿226813; 4P¿226815; 4P-226817; 4P-226818; 4P¿226819; 4P-226820; 4P-226821; 4P-226822
Where was it sold?
Distributed in OK and FL.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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