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Recall Observatory FDA recall evidence

Device product

Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

Z-1011-2013

February 26, 2013

Class III

Product summary

Firm
Cooper Surgical, Inc.
Event
Event 64531
Status
Terminated
Classification
Class III
Quantity
70 units
Official record key
device-enforcement:Z-1011-2013

Official wording

Reason: Pessary mislabeled outer package may not reflect the size of the product contained in the package

Code information: Lot Number:117376

Distribution pattern: Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled