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Sapphire Multi-Therapy and Epidural Infusion Pumps (2016-04-25)
- Starting date:
- April 25, 2016
- Posting date:
- May 16, 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-58384
Affected products
-
Sapphire Multi-Therapy Infusion Pump
-
Sapphire Epidural Infusion pump
Reason
Potential for false air-in-line alarms when initiating iron sucrose infusions at concentrations between 0.7 mg/ml and 2.8 mg/ml.
Affected products
A. Sapphire Multi-Therapy Infusion Pump
Lot or serial number
All serial Numbers
Model or catalog number
- 15031-000-0013
- 15031-000-0032
- 15032-000-0001
- 15038-000-0003
- 17000-028-0014
- 17000-028-0020
- 17000-028-0021
- 17000-028-0064
- 17000-031-0001
- 17000-031-0004
- 17000-031-0028
- 17000-033-0003
Companies
- Manufacturer
-
Q Core Medical Ltd.
29 Yad Haruzim St., P.O. Box 8639,
Netanya
4250529
ISRAEL
B. Sapphire Epidural Infusion pump
Lot or serial number
All serial Numbers
Model or catalog number
15032-000-0031
Companies
- Manufacturer
-
Q Core Medical Ltd.
29 Yad Haruzim St., P.O. Box 8639,
Netanya
4250529
ISRAEL