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Health product recall

ENA HRI TIPS (2016-07-14)

Starting date:
July 14, 2016
Posting date:
July 29, 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-59618

Affected products

A. ENA HRI TIPS

Reason

Material error of the tips has been determined as the cause. The injection mold for producing the tips is damaged by wear and tear at certain points, so that the plastic shows reduced mechanical stability.

Affected products

A. ENA HRI TIPS

Lot or serial number
  • 2015006968
  • 2015006969
  • 2015008946
  • 2016008946
Model or catalog number
  • EHRTUD2
  • EHRTUD3
  • EHRTUE1
Companies
Manufacturer
MICERIUM S.P.A
ViA G MARCONI 83
AVEGNO, GENOVA
16036
ITALY