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Inflatoball Pessary and Inflatoball Pessary Kit
- Starting date:
- April 10, 2017
- Posting date:
- May 2, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-63140
Reason
These products are being recalled due to a labeling error on the secondary package. The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the instructions for use (IFU) correctly states that the pessary is manufactured from latex rubber.
Affected products
Inflatoball Pessary and Inflatoball Pessary Kit
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
MXPINFL
MXPINFM
MXPINFS
MXPINFXL
Companies
- Manufacturer
-
Coopersurgical Inc.
95 Corporate Drive
Trumbull
06611
Connecticut
UNITED STATES