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Recall Observatory FDA recall evidence

Device product

CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02

Z-1239-2015

February 09, 2015

Class II

Product summary

Firm
CooperSurgical, Inc.
Event
Event 70502
Status
Terminated
Classification
Class II
Quantity
95 units
Official record key
device-enforcement:Z-1239-2015

Official wording

Reason: Incorrect size printed on the Milex Pessary Kit packaging label

Code information: Lot numbers: 144351, 142789

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect size printed on the Milex Pessary Kit packaging label