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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:204552

Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 2000342

Official recall number

Z-0655-2024

Evidence summary

Product code
DYB
Recall status
Open, Classified
Event initiated
November 07, 2023
Root cause
Process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0655-2024

Field note

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