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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:189251

Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075275

Official recall number

Z-0049-2022

Evidence summary

Product code
NCX
Recall status
Terminated
Event initiated
August 06, 2021
Root cause
Labeling design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0049-2022