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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:143987

ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

Official recall number

Z-1029-2016

Evidence summary

Product code
DRE
Recall status
Terminated
Event initiated
February 17, 2016
Root cause
Process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1029-2016

Field note

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