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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Product Detail

Product Description Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00 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.
Recall Number Z-1012-2013
Classification Class III
Code Info Lot Number:121784
Product Distributed Qty 20 units
Reason For Recall Pessary mislabeled outer package may not reflect the size of the product contained in the package

Event Detail

Event Id 64531
Product Type Devices
Status Ongoing
Recalling Firm Cooper Surgical, Inc.
City Trumbull
State CT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand.
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