Date Initiated by Firm | February 26, 2013 |
Date Posted | March 27, 2013 |
Recall Status1 |
Terminated 3 on March 04, 2014 |
Recall Number | Z-1004-2013 |
Recall Event ID |
64531 |
510(K)Number | K904026 K904774 |
Product Classification |
Pessary, vaginal - Product Code HHW
|
Product | 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. |
Code Information |
Lot Number:117301 |
Recalling Firm/ Manufacturer |
Cooper Surgical, Inc. 75 Corporate Dr Trumbull CT 06611-1350
|
For Additional Information Contact | Same 203-601-9825 |
Manufacturer Reason for Recall | Pessary mislabeled outer package may not reflect the size of the product contained in the package |
FDA Determined Cause 2 | 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 in Commerce | 80 units |
Distribution | Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and
Thailand. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = HHW
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