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Health product recall

ENVISION FLEX+, MOUSE, HIGH PH FOR AUTOMATED LINK PLATFORMS (2016-07-08)

Starting date:
July 8, 2016
Posting date:
August 26, 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-59962

Affected Products

ENVISION FLEX+, MOUSE, HIGH PH FOR AUTOMATED LINK PLATFORMS 

Reason

Customers complaints of either no staining or inconsistent staining with lot 10112886 (k8000) and lot 10112879 (k8002) of this product have been received.

Affected products

ENVISION FLEX+, MOUSE, HIGH PH FOR AUTOMATED LINK PLATFORMS 

Lot or serial number

10112879
10112879
 

Model or catalog number

K8002
K8002
 

Companies
Manufacturer
DAKO Denmark A/S
Produktionsvej 42
Glostrup, Copenhagen
2600
DENMARK