Device product
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.
Z-1012-2013
Product summary
- Event
- Event 64531
- Status
- Terminated
- Classification
- Class III
- Quantity
- 20 units
- Official record key
device-enforcement:Z-1012-2013
Official wording
Reason: Pessary mislabeled outer package may not reflect the size of the product contained in the package
Code information: Lot Number:121784
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
mislabeled