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Terminated

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

FDA Recall Z-1015-2015 · Posted 2015-01-27

Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeKDI
Date Initiated2014-12-16
Date Terminated2021-01-29
Product Quantity10

Reason for Recall

Unqualified power assemblies shipped to customers.

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed in OK and FL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121421FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)Fresenius Medical Care North America, Design Cente · 2013-01-17K121341FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEMFresenius Medical Care North America · 2012-12-06K994267FRESENIUS 2008KFresenius Medical Care · 2000-03-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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