—#132154

Product

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 product code: KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K121341, K121421, K994267
Affected lot / code info: 4P¿226813; 4P¿226815; 4P-226817; 4P-226818; 4P¿226819; 4P-226820; 4P-226821; 4P-226822

Why it was recalled

Unqualified power assemblies shipped to customers.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: Distributed in OK and FL.

Timeline

Recall initiated: 2014-12-16
Posted by FDA: 2015-01-27
Terminated: 2021-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132154. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.