Z-1009-2013 Class III Terminated
FDA device recall Z-1009-2013 was initiated by Cooper Surgical, Inc. on February 26, 2013 and is designated Class III. Reason for recall: Pessary mislabeled outer package may not reflect the size of the product contained in the package The recall status is terminated (terminated March 4, 2014). Affected quantity: 275 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2013
- Initiation Date
- February 26, 2013
- Termination Date
- March 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 275 units
Product Description
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.
Reason for Recall
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Distribution Pattern
Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand.
Code Information
Lot Number:117560