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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pump, infusion, insulin bolus
Regulation Description Infusion pump.
Definition The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.
Product CodeOPP
Regulation Number 880.5725
Device Class 2

Device Problems
Loss of or failure to bond 3
Defective component 3
Human-Device Interface Issue 2
Failure to Adhere or Bond 1
Device Issue 1
Dislodged or dislocated 1
Detachment of device component 1
Contamination during use 1
Leak 1
Failure to read input signal 1
Total Device Problems 15

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Zyno Medical LLC II Mar-29-2013

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