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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:152132

Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area

Official recall number

Z-1209-2017

Evidence summary

Product code
KDQ
Recall status
Terminated
Event initiated
December 23, 2016
Root cause
Process control
Source snapshot
d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product
Z-1209-2017

Field note

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