Recall Z-1011-2013
Cooper Surgical, Inc. · initiated February 26, 2013
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 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.
Codes / lots: Lot Number:117376
Reason for recall
Pessary mislabeled outer package may not reflect the size of the product contained in the package
FDA-determined cause: Packaging process control
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.
Details
- Recall number
- Z-1011-2013
- Initiated
- February 26, 2013
- Posted by FDA
- March 27, 2013
- Terminated
- March 4, 2014
- Product code
- HHW – Pessary, Vaginal
- Quantity
- 70 units
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Australia, Canada, Colombia, Demarkt, France, Holland, New ZeaJand, and Thailand.
- Recalling firm
- Cooper Surgical, Inc., Trumbull, CT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1004-2013 Class III | Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex Part Number:…Pessary mislabeled outer package may not reflect the size of the product contained in the package | 02/26/2013Terminated |
| Z-1005-2013 Class III | Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part Number:…Pessary mislabeled outer package may not reflect the size of the product contained in the package | 02/26/2013Terminated |
| Z-1006-2013 Class III | Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Number:…Pessary mislabeled outer package may not reflect the size of the product contained in the package | 02/26/2013Terminated |
| Z-1007-2013 Class III | Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number:…Pessary mislabeled outer package may not reflect the size of the product contained in the package | 02/26/2013Terminated |
| Z-1008-2013 Class III | Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXPCOND00…Pessary mislabeled outer package may not reflect the size of the product contained in the package | 02/26/2013Terminated |
| Z-1009-2013 Class III | Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: MXPGE2-3/4 A…Pessary mislabeled outer package may not reflect the size of the product contained in the package | 02/26/2013Terminated |
| Z-1010-2013 Class III | Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE3- A pessary…Pessary mislabeled outer package may not reflect the size of the product contained in the package | 02/26/2013Terminated |
| Z-1012-2013 Class III | Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00…Pessary mislabeled outer package may not reflect the size of the product contained in the package | 02/26/2013Terminated |