0.9% Sodium Chloride Injection, 1000 mL (2017-05-10)

Starting date:
May 10, 2017
Posting date:
May 19, 2017
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-63340

Reason

The recall is conducted due to the potential for leakage of the interior parenteral/intravenous solution bag.

Depth of distribution

Dialysis Unit Nephrologists, Nurses and Technicians;
Home Hemodialysis Program Co-ordinators and Home patients

Affected products

0.9% Sodium Chloride Injection, 1000 mL

DIN, NPN, DIN-HIM

DIN 02311798

Dosage form

Intravenous

Strength

0.9% sodium chloride

Lot or serial number

  • 16EU05011
  • 16EU05012
  • 16EU05013
  • 16DU05064

Companies

Recalling Firm
Fresenius Medical Care Canada Inc.
45 Staples Avenue, Suite 110
Richmond Hill
L4B 4W6
Ontario
CANADA
Marketing Authorization Holder
Fresenius Medical Care North America
920 Winter Street
Waltham
Massachusetts
UNITED STATES