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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device central venous catheter tray (kit)
Regulation Description Venous blood pressure manometer.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOFF
Regulation Number 870.1140
Device Class 2

Device Problems
Crack 1
Device operates differently than expected 1
Material integrity issue 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 1 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medline Industries Inc II Aug-25-2015
2 Tri-State Hospital Supply Corporation II Jul-07-2009

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