Health product recall

NxStage PureFlow Solution(2021-02-26)

Starting date:
February 26, 2021
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-75087



Last updated:
2021-03-08

Summary

  • Product:
    NxStage PureFlow Solution

Reason

Affected lot was exposed to temperatures outside of the recommended storage conditions.

Depth of distribution

Healthcare Establishments

Affected products

NxStage PureFlow Solution

DIN, NPN, DIN-HIM

DIN 02443295

Dosage form

Solution

Strength

CALCIUM CHLORIDE 0.221 G / L, DEXTROSE 1.1 G / L, MAGNESIUM CHLORIDE 0.102 G / L, POTASSIUM CHLORIDE 0.15 G / L,SODIUM CHLORIDE 5.552 G / L, SODIUM LACTATE 8.408 G / L

Lot or serial number

Q2010178

Companies

Recalling Firm

DSA Healthcare Imports Inc.

1660 North Service Rd E

Oakville

L6H 7G3

Ontario

CANADA

Marketing Authorization Holder

NXSTAGE MEDICAL INC.

350 Merrimack Street

Lawrence

01843

Massachusetts

UNITED STATES