Recall Z-0185-2014— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-0185-2014
Creator: U.S. Food and Drug Administration
Published: 2013-08-29

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2013-08-29, terminated 2021-02-11. It names one FDA 510(k) clearance: K070049. Product: Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.. Reason: Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-08-29
Terminated: 2021-02-11
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K070049 — FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTORFresenius Medical Care North America·cleared 2011-02-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

Reason for recall

Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss

Data sourced from openFDA. This site is unofficial and independent of the FDA.