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CombiSet

Fresenius Medical Care Holdings, Inc. · Model 03-2962-3 · UDI-DI 00840861100330

ONW Prescription

510(k) clearances

137

Adverse events (25 deaths)

Recalls

Facilities

Description

Pre-pump, 8.0 mm, Home Hemo with prime bag

Recalls

Date	Firm	Reason
2013-08-29	Fresenius Medical Care Holdings, Inc.	Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
2013-08-29	Fresenius Medical Care Holdings, Inc.	Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
2013-08-29	Fresenius Medical Care Holdings, Inc.	Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
2011-05-04	Fresenius Medical Care Holdings, Inc.	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 orde

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.