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SAPPHIRE MULTI-THERAPY INFUSION PUMP (2015-07-06)
- Starting date:
- July 6, 2015
- Posting date:
- July 21, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-54318
Affected Products
A. SAPPHIRE MULTI-THERAPY INFUSION PUMP
Reason
When using Epidural mode with patient bolus, the amount of medication delivered may be greater than programmed. In the Sapphire pump, as in all infusion systems, external factors may cause fluctuations in flow rate accuracy
Affected products
A. SAPPHIRE MULTI-THERAPY INFUSION PUMP
Lot or serial number
- 163111301
- 163111303
- 163113601
- 163116501
- 163121301
- 163121303
- 163123601
- 163126501
Model or catalog number
- 15031-000-0001
- 15031-000-0013
- 15032-000-0001
- 15032-000-0011
Companies
- Manufacturer
-
Q Core Medical Ltd.
29 Yad Haruzim St., P.O. Box 8639,
Netanya
4250529
ISRAEL