—#103240

Product

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 product code: ODX — Autonomous Extracorporeal Blood Leak Detector/Alarm
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K070049
Affected lot / code info: Product Code: 03-2962-3 Lot Numbers: 11ER01800 11ER01801 11ER01802 11ER01804 Exp. Date 05-2014

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2011-08-11
Posted by FDA: 2011-09-20
Terminated: 2016-08-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103240. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.