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Terminated

Fresenius Granuflo 1 Mixer Dissolution Unit - Tested, and Granuflo Dissolution Tank, Model Numbers G047-80101 and RTLG047-80101, Manufactured by Fresenius USA Inc., Walnut Creek, CA

FDA Recall Z-2226-2010 · Posted 2010-08-15

Recalling FirmFresenius Medical Care North America
Recall StatusTerminated
Product CodeKPO
Date Initiated2009-11-20
Date Terminated2011-02-07
Product Quantity957

Reason for Recall

Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.

Firm Action

An urgent device recall notification was sent to all consignees. Customers are asked to inspect cords for defects, and are refered to preventive maintenance requirements in the manual. Customers who identify the defective cords will be instructed to discontinue use as soon as possible without jeopardizing patient care. Customers are instructed to monitor cords regularly, and pay attention to machines that are frequently plugged or unplugged. Personnel are instructed to not use the cord to unplug the device from the wall (yanking the plug from the wall) and to refrain from rolling over the cord or plug.

Root Cause

Component design/selection

Distribution Pattern

Product distributed to 5404 customers throughout the US and the world.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K911459GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXINGFresenius USA, Inc. · 1991-07-17

Official Source

View FDA Recall →

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

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