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Recall Observatory FDA recall evidence

Device product

FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160

Z-2468-2019

July 10, 2019

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 83478
Status
Terminated
Classification
Class II
Quantity
250 units
Official record key
device-enforcement:Z-2468-2019

Official wording

Reason: The filter capacity is not achieved due to damage of the filter membrane.

Code information: Lot # 0061526085 UDI: 04046964941054

Distribution pattern: CA FL MO TX MN AL GA NC IL PA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The filter capacity is not achieved due to damage of the filter membrane.