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
This recall has been terminated (originally issued January 27, 2015).
- Recall Initiated
- December 16, 2014
- Posted
- January 27, 2015
- Terminated
- January 29, 2021
- Recall Number
- Z-1015-2015
- Quantity
- 10
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Unqualified power assemblies shipped to customers.
Distribution
Distributed in OK and FL.
Lot / Code Info
4P¿226813; 4P¿226815; 4P-226817; 4P-226818; 4P¿226819; 4P-226820; 4P-226821; 4P-226822
Root Cause
Under Investigation by firm
Action Taken
Consignees were notified of the recall via letter sent on 12/18/2014 via certified mail. The letter informs consignees of the recall and requests that they take the following steps: Please check your stock for any 50 Hz Power Supplies (P/N 190092) with the name Electro Assemblies, LLC which is visible on the Transformer contained inside the Power Supply and discontinue use. Place the product in a secure, segregated area. Please contact your Fresenius Technical Services at 1-800-227-2572 option 4 then option 1, and reference the Field Action Number above. They will issue you a Return Good Authorization so you can return this product. that a reply form is completed and returned via fax or scanned email copy. In addition, consignees are asked to complete a reply form and return via fax/mail.