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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device port, protector/cushion
Regulation Description Subcutaneous, implanted, intravascular infusion port and catheter.
Definition Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports.
Product CodeOBK
Regulation Number 880.5965
Device Class 2

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 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II Nov-06-2013

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