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MICROSTIC PLUS
- Starting date:
- September 8, 2016
- 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-60444
Affected Products
Reason
An issue was identified with the stiffer coaxial micro-introducer 4FR and 5FR after a field complaint reported that the rotating luer detached from the dilator hub during use. The function of the rotating luer is to fasten the dilator to the shield during insertion. Affected lots have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath.
Affected products
MICROSTIC PLUS
Lot or serial number
- 11149822
Model or catalog number
- 497884
Companies
- Manufacturer
-
Argon Medical Devices Inc.
1445 Flat Creek Road
Athens
75751
Texas
UNITED STATES