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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:167075

ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

Official recall number

Z-0069-2019

Evidence summary

Product code
FMG
Recall status
Completed
Event initiated
August 20, 2018
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0069-2019

Field note

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