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Advanced Perfusion System 1, Base Unit (2014-06-27)
- Starting date:
- June 27, 2014
- Posting date:
- July 10, 2014
- 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-40405
Recalled Products
Advanced Perfusion System 1, Base Unit
Reason
Terumo CVS has determined that the updated information in the operator's manual would improve patient safety by mitigating any ambiguity and by providing accurate performance ranges that align with device operation. Updated labeling will be provided to users in the field.
Affected products
Advanced Perfusion System 1, Base Unit
Lot or serial number
0013
0017
0020
0021
0142
0144
0146
0170
0396
1177
1312
1340
1360
1361
1367
1374
Model or catalog number
801763
Companies
- Manufacturer
-
Terumo Cardiovascular Systems Corp.
6200 Jackson Road
Ann Arbor
48103
Michigan
UNITED STATES