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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device applicator, absorbent tipped, sterile
Regulation Description Absorbent tipped applicator.
Product CodeKXG
Regulation Number 880.6025
Device Class 1

Device Problems
Detachment of Device or device Component 9
Appropriate Term/Code Not Available 3
Insufficient Information 3
Material Separation 1
Break 1
Product Quality Problem 1
Unraveled Material 1
Material Integrity Problem 1
Adverse Event Without Identified Device or Use Problem 1
Material Fragmentation 1
Total Device Problems 22

Recalls
Manufacturer Recall Class Date Posted
1 Puritan Medical Products Co., LLC II Mar-13-2015

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