This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
SealApex Xpress
- Starting date:
- August 31, 2016
- 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-60272
Affected Products
SealApex Xpress
Reason
Labelling error with one(1) lot of Sealapex Xpress. The product's syringe label correctly identifies the expiration date as 2016-11. Some carton labels incorrectly identify the expiration date as 2017-11. Product used past the expiration date of 2016-11 may not perform as intended. Such product may exhibit crystals in the catalyst paste.
Affected products
SealApex Xpress
Lot or serial number
5-1310
Model or catalog number
33639
Companies
- Manufacturer
-
Ormco Corporation
1332 South Lone Hill Avenue
Glendora
91740
California
UNITED STATES