Recall Z-1004-2013 ยท HHW Pessary, Vaginal
Cooper Surgical, Inc.
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.
| Date | Mar 27, 2013 (initiated Feb 26, 2013) |
| Status | Terminated |
| Reason | Pessary mislabeled outer package may not reflect the size of the product contained in the package |
| Root cause | Packaging process control |
| Action | Cooper Surgical initiateda recall by letter on February 26, 2013, advising accounts to examine inventory and report quantity back to the firm for replacement. For questions customers should call Customer Service at 1-800-243-2974. For questions regarding this recall call 203-601-9825. |
| Quantity | 80 units |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand. |
| FDA record | Open on fda.gov |