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Recall Observatory FDA recall evidence

Device product

026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting

Z-2085-2021

April 28, 2021

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 87998
Status
Terminated
Classification
Class II
Quantity
6 Cases
Official record key
device-enforcement:Z-2085-2021

Official wording

Reason: Exposed to freezing temperatures due to refrigerated truck malfunctions

Code information: Lot Number: 20HR08054 UDI: (01)00840861101115

Distribution pattern: US Distribution to: TX only

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Exposed to freezing temperatures due to refrigerated truck malfunctions