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Microfil Composite Instruments (2017-04-20)
- Starting date:
- April 20, 2017
- Posting date:
- June 12, 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-63580
Affected Products
A. #96041- Gold Microfil
B. #96042- Green Microfil
C. #96044- Set Of 3 Microfil (Gold, Green, Blue)
Reason
Almore International Inc., is voluntarily recalling the following Microfil Composite instruments that were shipped between January 1, 2017 and March 17, 2017. Microfil composite instruments in these shipments contained the sterile symbol on their packaging label inserts, indicating that the products are sold as sterile devices. These products are not sterile. These devices are intended to be sterile prior to use, but they were distributed in packaging with a sterile symbol. We are concerned customers could misinterpret this labeling and assume this device is sterile.
Affected products
A. #96041- Gold Microfil
Lot or serial number
Not Applicable
Model or catalog number
- 96041
- 96041
Companies
- Manufacturer
-
Almore International Inc.
10950 SW 5th Street, Suite 270
Beaverton
97005
Oregon
UNITED STATES
B. #96042- Green Microfil
Lot or serial number
Not Applicable
Model or catalog number
96042
96042
Companies
- Manufacturer
-
Almore International Inc.
10950 SW 5th Street, Suite 270
Beaverton
97005
Oregon
UNITED STATES
C. #96044- Set Of 3 Microfil (Gold, Green, Blue)
Lot or serial number
Not Applicable
Model or catalog number
96044
96044
Companies
- Manufacturer
-
Almore International Inc.
10950 SW 5th Street, Suite 270
Beaverton
97005
Oregon
UNITED STATES