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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot Number:121784 Class III Pessary mislabeled outer package may not reflect the size of the product contained in the package 20 units Z-1012-2013
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. Lot Number:117376 Class III Pessary mislabeled outer package may not reflect the size of the product contained in the package 70 units Z-1011-2013
Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE3- 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. Lot Number:117568 Class III Pessary mislabeled outer package may not reflect the size of the product contained in the package 175 units Z-1010-2013
Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: MXPGE2-3/4 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. Lot Number:117560 Class III Pessary mislabeled outer package may not reflect the size of the product contained in the package 275 units Z-1009-2013
Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXPCOND00 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. Lot Number:114287 Class III Pessary mislabeled outer package may not reflect the size of the product contained in the package 31 units Z-1008-2013
Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXKPCOND00 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. Lot Number:114288 Class III Pessary mislabeled outer package may not reflect the size of the product contained in the package 36 units Z-1007-2013
Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Number: MXKPCONDS00 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. Lot Number:111732 Class III Pessary mislabeled outer package may not reflect the size of the product contained in the package 45 units Z-1006-2013
Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part Number: MXPCONDS05 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. Lot Number:117443 Class III Pessary mislabeled outer package may not reflect the size of the product contained in the package 18 units Z-1005-2013
Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex Part Number: MXPCON04 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. Lot Number:117301 Class III Pessary mislabeled outer package may not reflect the size of the product contained in the package 80 units Z-1004-2013
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