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