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Recall Observatory FDA recall evidence

Device product

EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N

Z-1938-2015

May 07, 2015

Class II

Product summary

Firm
Atrium Medical Corporation
Event
Event 71023
Status
Terminated
Classification
Class II
Quantity
390 cases
Official record key
device-enforcement:Z-1938-2015

Official wording

Reason: Chest drains have a missing o-ring

Code information: Lot Number: 222516

Distribution pattern: Nationwide Canada, Germany

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Chest drains have a missing o-ring