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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:128750

Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose tips, 50 applicator brushes, and a product insert.

Official recall number

Z-2128-2014

Evidence summary

Product code
KLE
Recall status
Terminated
Event initiated
July 16, 2014
Root cause
Process design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2128-2014