Device product
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.
Z-1009-2013
Product summary
- Event
- Event 64531
- Status
- Terminated
- Classification
- Class III
- Quantity
- 275 units
- Official record key
device-enforcement:Z-1009-2013
Official wording
Reason: Pessary mislabeled outer package may not reflect the size of the product contained in the package
Code information: Lot Number:117560
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