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Health product recall

CRIT-LINE Blood Chamber (2015-05-25)

Starting date:
May 25, 2015
Posting date:
July 7, 2015
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-54006

Recalled Product

A. CRIT-LINE Blood Chamber

Reason

An increased number of complaints have been received in the US pertaining to blood chamber connection leaks during the use of the CRIT-LINE? Blood chamber.

Affected products

A. CRIT-LINE Blood Chamber

Lot or serial number
  • 120503
  • 120504
  • 120601
  • 120903
  • 121103
  • 130403
  • 130502
  • 130806
  • 130901
  • 131003
  • 131101
  • 131107
  • 131113
  • 131114
  • 131208
  • 14031103
  • 14031202
  • 14031309
  • 14031310
  • 14041304
  • 14051304
  • 14071302
  • 14071303
  • 14071314
Model or catalog number
  • 10021021
Companies
Manufacturer

FRESENIUS USA MANUFACTURING INC

695 NORTH 900 WEST

Kaysville

84037

Utah

UNITED STATES