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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device autonomous extracorporeal blood leak detector/alarm
Regulation Description Hemodialysis system and accessories.
Definition To detect the presence of blood leaking from an extracorporeal connection or needle site in hemodialysis patients and alert the user or attending staff. The device detects colormetric, chemical, or light modulation caused by exposure to leaking blood.
Product CodeODX
Regulation Number 876.5820
Device Class 2

Device Problems
Material disintegration 2
Device operates differently than expected 1
Total Device Problems 3

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Fresenius Medical Care Holdings, Inc. II Sep-20-2011

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