Fresenius 2008K@home The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.
FDA Recall Z-3083-2011 · Posted 2011-08-29
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Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeONW
Date Initiated2011-05-04
Date Terminated2014-08-14
Product Quantity705 units
Reason for Recall
Upgrade software to implement new on screen graphics and instructions, the addition of a bracket on the side of the machine to temporarily hold the bloodlines during set up in order to conform to approved 510(k)
Firm Action
Fresenius Medical NA issued a formal field correction notification dated May 4 ,2011, sent by certified mail with return receipt requested. The letter identified the product the problem and the action needed to be taken by the customer.
The customer was notified of the retrofit that would be done to their machines.
The patients' facilities were made aware of the changes that would be made to each of their patient's 2008K@home machines on May 4, 2011. On May 13, 2011, all facilities with active 2008K@home machines were sent a notification letter of the retrofit.
Please return the receipt for confirmation that you have received this notice.
Please call (781) 699-2053, to schedule a certified technician to conduct the machine retrofit.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution. Canada - FMCNA is not conducting the recall to Canada, as Health Canada did not require the same modifications to the machines
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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