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Coiled Tube Infusor (2014-04-10)
- Starting date:
- April 10, 2014
- Posting date:
- April 30, 2014
- 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-39261
Recalled Products
Coiled Tube Infusor
Reason
Baxter Corporation is issuing a safety alert for coiled tube infusors noting that a labeling error, previously communicated to customers on March 5, 2014, when combined with all other use factors, can contribute to infusion rates in excess of 30 percent greater than the nominal (labeled) flow rate. Delivery of medication at an infusion rate faster than intended may lead to toxicity and changes to efficacy that require medical intervention.
Affected products
Coiled Tube Infusor
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
2C1071KJP
2C1073KJP
2C1075KJP
2C1080KJP
2C1082KJP
Companies
- Manufacturer
-
Baxter Healthcare SA
Zurich
8010
SWITZERLAND