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Consepsis Indispense Syringe Refill 30mL
- Starting date:
- March 6, 2017
- Posting date:
- April 4, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-62908
Reason
It was identified that the shelf life of the product is labeled with the incorrect shelf-life of November 2020 rather than the correct shelf-life November 2018. The mislabeling extends the intended shelf-life of the product by two years. This label misidentification was discovered during Ultradent's batch record review process. No doctor or patient complaints have been received to date.
Affected products
Consepsis Indispense Syringe Refill 30mL
Lot or serial number
BD86D
Model or catalog number
689
Companies
- Manufacturer
-
Ultradent Products, Inc.
505 West 10200 South
South Jordan
84095
Utah
UNITED STATES