FDAFDA · Food and drugs·Recall number Z-1005-2013
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.
Published April 3, 2013 · Recall initiated: February 26, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Pessary mislabeled outer package may not reflect the size of the product contained in the package
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cooper Surgical, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand.
- Lot
- Lot Number:117443
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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