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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

Device Problems
Material Fragmentation 157
Material Frayed 141
Incomplete or Missing Packaging 78
Material Separation 62
Packaging Problem 55
Particulates 45
Detachment Of Device Component 42
Component Missing 32
Material Integrity Problem 29
Detachment of Device or device Component 25
Device Packaging Compromised 15
Material Disintegration 13
Appropriate Term/Code Not Available 12
Unraveled Material 9
Device Contamination with Chemical or Other Material 7
Device Misassembled During Manufacturing / Shipping 6
Flaked 6
Nonstandard device 4
Manufacturing, Packaging or Shipping Problem 4
Adverse Event Without Identified Device or Use Problem 4
Break 4
Product Quality Problem 3
Delivered as Unsterile Product 3
Device Operates Differently Than Expected 3
Defective Component 3
Contamination During Use 2
False Negative Result 2
Torn Material 2
Disassembly 2
Material Deformation 2
Component Falling 1
Incorrect Measurement 1
Misassembled 1
Device Sensing Problem 1
Device Contaminated during manufacture or shipping 1
Sticking 1
Device Or Device Fragments Location Unknown 1
Explanted 1
Unsealed Device Packaging 1
Degraded 1
Short Fill 1
Thread 1
Device-Device Incompatibility 1
Total Device Problems 785

Recalls
Manufacturer Recall Class Date Posted
1 American Surgical Company II May-26-2016
2 Covidien LLC II Mar-19-2018
3 Covidien LP II Feb-08-2018
4 Medical Action Industries Inc II Mar-28-2019
5 Medical Action Industries Inc II Dec-22-2018
6 Medical Action Industries Inc II May-17-2017
7 Rainbow Specialty & Health Products II Dec-23-2015

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