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Accusorb MRI Products (2014-06-01)
- Starting date:
- June 1, 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-55632
Affected Products
A. Accusorb large blanket 36" X 36"
B. Accusorb Arm Sleeve
C. Accusorb Knee Straps
D. Accusorb Poncho
E. Accusorb Leg Wrap 24" X 30"
F. Accusorb Torso Wrap 52" X 36"
G. Accusorb Breast Shield
H. Accusorb Boot
Reason
Safety and use instructions were updated to increase the spacing of the blanket between the patient and the MRI from 1 to 2 centimetres.
Affected products
A. Accusorb large blanket 36" X 36"
Lot or serial number
All lots.
Model or catalog number
MRI-01
Companies
- Manufacturer
-
MWT Materials, Inc.
90 Dayton Avenue, Building 6E
Pasaic
07055
New Jersey
UNITED STATES
B. Accusorb Arm Sleeve
Lot or serial number
All lots.
Model or catalog number
MRI-02
Companies
- Manufacturer
-
MWT Materials, Inc.
90 Dayton Avenue, Building 6E
Pasaic
07055
New Jersey
UNITED STATES
C. Accusorb Knee Straps
Lot or serial number
All lots.
Model or catalog number
MRI-03
Companies
- Manufacturer
-
MWT Materials, Inc.
90 Dayton Avenue, Building 6E
Pasaic
07055
New Jersey
UNITED STATES
D. Accusorb Poncho
Lot or serial number
All lots.
Model or catalog number
MRI-04
Companies
- Manufacturer
-
MWT Materials, Inc.
90 Dayton Avenue, Building 6E
Pasaic
07055
New Jersey
UNITED STATES
E. Accusorb Leg Wrap 24" X 30"
Lot or serial number
All lots.
Model or catalog number
MRI-05
Companies
- Manufacturer
-
MWT Materials, Inc.
90 Dayton Avenue, Building 6E
Pasaic
07055
New Jersey
UNITED STATES
F. Accusorb Torso Wrap 52" X 36"
Lot or serial number
All lots.
Model or catalog number
MRI-06
Companies
- Manufacturer
-
MWT Materials, Inc.
90 Dayton Avenue, Building 6E
Pasaic
07055
New Jersey
UNITED STATES
G. Accusorb Breast Shield
Lot or serial number
All lots.
Model or catalog number
MRI-07
Companies
- Manufacturer
-
MWT Materials, Inc.
90 Dayton Avenue, Building 6E
Pasaic
07055
New Jersey
UNITED STATES
H. Accusorb Boot
Lot or serial number
All lots.
Model or catalog number
MRI-08
Companies
- Manufacturer
-
MWT Materials, Inc.
90 Dayton Avenue, Building 6E
Pasaic
07055
New Jersey
UNITED STATES