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Infusor, Infusor LV, Infusor XLV and Intermate - Portable Elastomeric Infusion Systems (2013-09-04)
- Starting date:
- September 4, 2013
- Posting date:
- October 28, 2013
- 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-36435
Recalled Products
A.Infusor - Portable Elastomeric Infusion System
B.Intermate - Portable Elastomeric Infusion System
C.Infusor LV - Portable Elastomeric Infusion System
D.Infusor XLV - Portable Elastomeric Infusion System
Reason
Baxter Corporation initiated important safety information regarding the infusor and intermate portable elastomeric infusion systems. Contact manufacturer for a listing of all product codes affected.
Baxter has received complaints for infusion flow rates greater than intended for the referenced portable elastomeric infusion systems. In many cases, the complaint details an over infusion of medication that is the result of uses inconsistent with the instructions for use.
Affected products
A.Infusor - Portable Elastomeric Infusion System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
More than 10 numbers, contact manufacturer
Companies
- Manufacturer
-
Baxter Healthcare SA
Zurich
8010
SWITZERLAND
B.Intermate - Portable Elastomeric Infusion System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 2C1730K
- 2C1732K
- 2C1734K
- 2C1740K
- 2C1742K
- 2C1744K
Companies
- Manufacturer
-
Baxter Healthcare SA
Zurich
8010
SWITZERLAND
C. Infusor LV - Portable Elastomeric Infusion System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 2C1008KP
- 2C1009KP
- 2C1156KP
Companies
- Manufacturer
-
Baxter Healthcare SA
Zurich
8010
SWITZERLAND
D. Infusor XLV - Portable Elastomeric Infusion System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 2C1168K
Companies
- Manufacturer
-
Baxter Healthcare SA
Zurich
8010
SWITZERLAND