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RENASYS EZ NEGATIVE PRESSURE WOUND THERAPY (2015-02-02)
- Starting date:
- February 2, 2015
- Posting date:
- April 2, 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-52761
Recalled Products
- RENASYS EZ NEGATIVE PRESSURE WOUND THERAPY
- RENASYS GO NEGATIVE PRESSURE WOUND THERAPY SYSTEM
Reason
The IFU amendments will remind customers that the dressing is to be checked regularly to ensure that pooling is not occurring beneath the dressing and remind users not to rely solely on the device alarms to ensure that therapy is being effectively delivered.
Affected products
A. RENASYS EZ NEGATIVE PRESSURE WOUND THERAPY
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
66800697
Companies
- Manufacturer
-
Smith & Nephew Inc.
970 Lake Carillon Drive Suite 110
St. Petersburg
33716
Florida
UNITED STATES
B. RENASYS GO NEGATIVE PRESSURE WOUND THERAPY SYSTEM
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
66800164
Companies
- Manufacturer
-
Smith & Nephew Inc.
970 Lake Carillon Drive Suite 110
St. Petersburg
33716
Florida
UNITED STATES