Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex Part Number: MXPCON04 A pessary is a medical
FDA device recall Z-1004-2013 · posted 2013-03-27 · Terminated
Recall details
- Recalling firm
- Cooper Surgical, Inc.
- Reason for recall
- Pessary mislabeled outer package may not reflect the size of the product contained in the package
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- HHW
- Quantity affected
- 80 units
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand.
- Date initiated
- 2013-02-26
- Date posted
- 2013-03-27
- Date terminated
- 2014-03-04
- Location
- Trumbull, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INGLAT-O-BALL (K904774) | Milex Products, Inc. | 1990-12-07 |
| INFLAT-O-BALL (K904026) | Milex Products, Inc. | 1990-10-10 |