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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pack, hot or cold, water circulating
Regulation Description Water circulating hot or cold pack.
Product CodeILO
Regulation Number 890.5720
Device Class 2


Premarket Reviews
ManufacturerDecision
ADROIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
AIRCAST, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BIO COMPRESSION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BURKE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ELBIO CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GAYMAR INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
HOLLISTER, INC.
  1
  SUBSTANTIALLY EQUIVALENT 6
INNOVATION SPORTS, INC.
  1
JUNIPER MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 6
SEABROOK MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 6
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPENCO
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  1

Device Problems
No Information 7
Scratched material 4
Break 4
Fluid leak 3
Improper flow or infusion 3
Leak 3
Spark 2
No Known Device Problem 2
Smoking 2
Improper or incorrect procedure or method 1
Insufficient flow or underinfusion 1
Unknown (for use when the device problem is not known) 1
Difficult or delayed activation 1
Device displays error message 1
Hole in material 1
Burn of device or device component 1
Crack 1
Device operates differently than expected 1
Electrical shorting 1
Misassembled 1
Pacing inadequately 1
Total Device Problems 42

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

Recalls
Manufacturer Recall Class Date Posted
1 Breg Inc II Feb-12-2013
2 Breg Inc, An Orthofix Company II Sep-04-2009
3 Cincinnati Sub-Zero Products Inc II Feb-19-2015
4 Cincinnati Sub-Zero Products Inc II Feb-04-2010
5 DeRoyal Industries Inc II Jan-27-2014
6 Pro Trainers' Choice Company II Jun-24-2011

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