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Recall Observatory FDA recall evidence

Device product

Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.

Z-2433-2019

July 22, 2019

Class II

Product summary

Firm
GETINGE US SALES LLC
Event
Event 83468
Status
Terminated
Classification
Class II
Quantity
1444 boxes worldwide
Official record key
device-enforcement:Z-2433-2019

Official wording

Reason: Reversed expiration and manufacturing date on the label

Code information: Lot # 1810, 1811 Part Number: 6677845 for 12 pcs, 6673717 for 1 pcs UDI Code: 17325710001988

Distribution pattern: US nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Reversed expiration and manufacturing date on the label