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Health product recall

SAPPHIRE MULTI-THERAPY INFUSION PUMP (2016-07-04)

Starting date:
July 4, 2016
Posting date:
July 19, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-59398

Affected products

A. SAPPHIRE MULTI-THERAPY INFUSION PUMP

Reason

Using Sapphire Multi-Therapy pumps with software version 13.21.1 in TPN mode and programming tapers may result in the deviations experienced by the customer, if the pump is not plugged to the AC adapter and the backlight feature is used.

Affected products

A. SAPPHIRE MULTI-THERAPY INFUSION PUMP

Lot or serial number

Version 13.21.1

Model or catalog number
  • "15031-000-0001
  • 15031-000-0032"
Companies
Manufacturer
Q Core Medical Ltd.
29 Yad Haruzim St., P.O. Box 8639,
Netanya
4250529
ISRAEL