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Swan-Ganz Catheter (2015-05-06)
- Starting date:
- May 6, 2015
- Posting date:
- June 3, 2015
- 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-53621
Recalled Products
A. Swan-Ganz Catheter
Reason
This product recall has been initiated as a result of the product from lot number 59860969 failing to meet the established statistical test for heparin activity. Catheters in this lot may be below the low end specification for heparin activity.
Affected products
A. Swan-Ganz Catheter
Lot or serial number
Lot 59860969
Model or catalog number
744HF75
Companies
- Manufacturer
-
Edwards Lifesciences Llc
1 Edwards Way
Irvine
California
UNITED STATES