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Health product recall

Medos Medizintechnik AG Products

Starting date:
November 13, 2012
Posting date:
January 7, 2013
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-16515

Recalled products

  1. Hilite 7000LT, Hollow Fibre Oxygenator, Rheoparin
  2. Hilite 2400LT, Rheoparin Coated, Hollow Fiber Oxygenator

Reason

Unlicensed devices not authorized through the Special Access Program (SAP) were recalled at a Canadian hospital.

Affected products

A. Hilite 7000LT, Hollow Fibre Oxygenator, Rheoparin

Lot or serial number

More than 10 numbers; contact manufacturer.

Model or catalog number

ME 6202 CL01

Companies
Manufacturer

Medos Medizintechnik AG

Obere Steinfurt 8-10

52222 Stolberg, Nordrhein-Westfalen

GERMANY



B. Hilite 2400LT, Rheoparin Coated, Hollow Fiber Oxygenator

Lot or serial number

More than 10 numbers; contact manufacturer.

Model or catalog number

ME 6205 CL01

Companies
Manufacturer

Medos Medizintechnik AG

Obere Steinfurt 8-10

52222 Stolberg, Nordrhein-Westfalen

GERMANY