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Cooper Surgical Incontinence Ring Flexible Pessary #4, 2… recallZ-1004-2013 · Cooper Surgical, Inc. · initiated Feb 26, 2013

Class III Terminated All recalls posted in March 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cooper Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Pessary mislabeled outer package may not reflect the size of the product contained in the package

FDA root cause category: Packaging process control

What the company is doing

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.

Recall details

Recall number
Z-1004-2013
Recall class
Class III
Status
Terminated
Initiated by the company
Feb 26, 2013
Posted by the FDA
Mar 27, 2013
Recalling firm
Cooper Surgical, Inc.
Quantity
80 units
Product code
HHW
FDA submissions
K904026, K904774
Distribution
Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand.

Product description

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 (models, lots, serial numbers)

Lot Number:117301

Other devices under the same FDA submission

1 device cleared under K904026, K904774 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 64531).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page