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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 136
Flaked 25
Material integrity issue 14
Material fragmentation 13
Material disintegration 11
Detachment of device component 10
Material separation 9
Packaging issue 6
Foreign material present in device 6
Incomplete or missing packaging 6
Unraveled material 5
Device packaging compromised 5
Detachment of device or device component 4
Other (for use when an appropriate device code cannot be identified) 4
Break 4
Device operates differently than expected 3
Excessive Manipulation 2
Device or device fragments location unknown 2
Manufacturing or shipping issue associated with device 2
Material deformation 2
Product quality issue 2
Reaction 1
Short fill 1
Sticking 1
Misassembled 1
Nonstandard device or device component 1
Unsealed device packaging 1
Particulates 1
Component(s), broken 1
Component falling 1
Degraded 1
Fire 1
Torn material 1
Unknown (for use when the device problem is not known) 1
Device sensing issue 1
Device-device incompatibility 1
Total Device Problems 286

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 1 0 2 0 1 0 0 1 1
Class III 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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