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Recall Observatory FDA recall evidence

Device product

Milex Arcing Diaphragm Size 95; Model Number: MXWS95

Z-1054-2016

February 16, 2016

Class II

Product summary

Firm
CooperSurgical, Inc.
Event
Event 73329
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-1054-2016

Official wording

Reason: The products have been identified to contain an incorrect size Diaphragm.

Code information: Lot# 130438

Distribution pattern: US Distribution to the states of : OR and NY

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The products have been identified to contain an incorrect size Diaphragm.