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Terminated

CombiSet True Flow" 2008K@home Bloodlines Fresenius Medical Care. Used for transferring blood during the hemodialysis treatment from the patient to the dialyzer (artificial kidney), removing extra water and waste products and then returning the filtered blood back to the patient

FDA Recall Z-3269-2011 · Posted 2011-09-20

Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeODX
Date Initiated2011-08-11
Date Terminated2016-08-24
Product Quantity118 cases

Reason for Recall

Blood lines coiling tabs #1 and #5 on the arterial line are not in the correct positions

Firm Action

Fresenius Medical Care sent out an "Urgent" recall notice dated August 11, 2011 to all affected customers . The letter included description of the product name, problem and asked them to examine their stock immediately and quarantine bloodlines from the recalled lots. Customers were asked to return the product to Fresenius. For information on this recall call the Fresenius Customer Service Team at 1-800-323-5188.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K070049FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTORFresenius Medical Care North America · 2011-02-03

Official Source

View FDA Recall →

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

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