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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:124845

11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. K7105-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

Official recall number

Z-0695-2014

Evidence summary

Product code
FPA
Recall status
Terminated
Event initiated
December 24, 2013
Root cause
Equipment maintenance
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0695-2014

Field note

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