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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device gauze/sponge, internal, x-ray detectable
Regulation Description Nonabsorbable gauze for internal use.
Product CodeGDY
Regulation Number 878.4450
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOSEAL
  SUBSTANTIALLY EQUIVALENT 3
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
LIFESTREAM INT'L, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ACTION INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material frayed 138
Material fragmentation 68
Flaked 25
Detachment of device component 21
Material integrity issue 17
Particulates 15
Material disintegration 12
Material separation 11
Incomplete or missing packaging 6
Foreign material present in device 6
Packaging issue 6
Detachment of device or device component 5
Device packaging compromised 5
Unraveled material 5
Other (for use when an appropriate device code cannot be identified) 4
Break 4
Device operates differently than expected 3
Product quality issue 2
Excessive Manipulation 2
Device or device fragments location unknown 2
Manufacturing or shipping issue associated with device 2
Material deformation 2
Device-device incompatibility 1
Sticking 1
Unsealed device packaging 1
Reaction 1
Component falling 1
Short fill 1
Nonstandard device or device component 1
Component(s), broken 1
Torn material 1
Misassembled 1
Unknown (for use when the device problem is not known) 1
Degraded 1
Device sensing issue 1
Fire 1
Total Device Problems 375

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 1 0 2 0 1 0 0 1 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 American Surgical Company II May-26-2016
2 Argon Medical Devices, Inc II Jun-02-2010
3 International Medsurg Connection, Inc. II May-10-2012
4 Medline Industries Inc II Sep-20-2008
5 Rainbow Specialty & Health Products II Dec-23-2015
6 Stryker Instruments Div. of Stryker Corporation II Mar-15-2010

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