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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:124073

Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark

Official recall number

Z-0595-2014

Evidence summary

Product code
FPA
Recall status
Terminated
Event initiated
November 19, 2013
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0595-2014

Field note

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