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Health product recall

FRESENIUS DIALYSATE DELIVERY AND HEMODIALYSIS SYSTEM (2016-03-10)

Starting date:
March 10, 2016
Posting date:
April 4, 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-57750

Affected products 

  1. FRESENIUS 2008K DIALYSATE DELIVERY SYSTEM
  2. FRESENIUS 2008K2 DIALYSATE DELIVERY SYSTEM
  3. 2008T HEMODIALYSIS SYSTEM CDX
  4. 2008K@HOME - REFURBISHED

Affected products

  1. FRESENIUS 2008K DIALYSATE DELIVERY SYSTEM

 

 

Lot or serial number

All lots

Model or catalog number
  • 190300
  • 190301
  • 190302
  • 190303
  • 190304
  • 190305
  • 190306
  • 190336
  • 190371
  • 190373
  • 190452
  • 365009-10-01
  • 365009-10-02
  • 365009-10-03
  • 677971
  • M30340
  • M30656
Companies
Manufacturer

Fresenius USA Inc.

4040 Nelson Avenue

Concord

94520

California

UNITED STATES



B. FRESENIUS 2008K2 DIALYSATE DELIVERY SYSTEM

 

Lot or serial number

All lots

Model or catalog number

190610

190630

190633

R190610

Companies
Manufacturer

Fresenius USA Inc.

4040 Nelson Avenue

Concord

94520

California

UNITED STATES



C. 2008T HEMODIALYSIS SYSTEM CDX

 

Lot or serial number

All lots

Model or catalog number

190573

190713

190729

190766

190908

R190713

R190766

RTLR190573

Companies
Manufacturer

Fresenius USA Inc.

4040 Nelson Avenue

Concord

94520

California

UNITED STATES



D. 2008K@HOME - REFURBISHED

Lot or serial number

All lots

Model or catalog number

190395

190653

191014

R190395

Companies
Manufacturer

Fresenius USA Inc.

4040 Nelson Avenue

Concord

94520

California

UNITED STATES