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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 182
Material fragmentation 99
Detachment of device component 34
Incomplete or missing packaging 32
Flaked 27
Particulates 26
Material separation 22
Material integrity issue 21
Packaging issue 21
Material disintegration 14
Device packaging compromised 13
Unraveled material 7
Foreign material present in device 6
Detachment of device or device component 5
Break 5
Other (for use when an appropriate device code cannot be identified) 4
Defective component 3
Component missing 3
Device operates differently than expected 3
No code available 3
Manufacturing or shipping issue associated with device 2
Material deformation 2
Torn material 2
Excessive Manipulation 2
Device or device fragments location unknown 2
Disassembly 2
Product quality issue 2
Reaction 1
Short fill 1
Sticking 1
Incorrect measurement 1
Misassembled 1
Nonstandard device or device component 1
Unsealed device packaging 1
Fire 1
Component(s), broken 1
Component falling 1
Degraded 1
Device misassembled during manufacturing or shipping 1
Unknown (for use when the device problem is not known) 1
Device sensing issue 1
Device-device incompatibility 1
Total Device Problems 559

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 1
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 Medical Action Industries Inc II May-17-2017
5 Medline Industries Inc II Sep-20-2008
6 Rainbow Specialty & Health Products II Dec-23-2015
7 Stryker Instruments Div. of Stryker Corporation II Mar-15-2010

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