September 3, 2019
Germany-based Fresenius said that two sets of its 4008 bloodlines (AV-Set B-R F00001124 and AV-Set SRB-R F00000257) containing a total of 25 batches experienced tube rupture that led to blood leakage.
A dialysis machine cannot detect the leaks, and Fresenius urged healthcare providers to immediately stop using the affected batches to avoid leaks and air entry to a patient’s bloodstream. The FDA has not classified the recall, and the company did not reveal the number of affected devices or whether any adverse events had been reported in connection with the leaks.
“We sincerely apologize for any inconvenience this may cause and we will provide you with a replacement as soon as possible,” the company said in a news release. “Fresenius Medical Care is committed to ensuring our products and services consistently meet the highest standards of quality and safety for patients and healthcare providers,”