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Medrad Intego PET Infusion System - Source Administration Sets
- Starting date:
- November 9, 2016
- Posting date:
- November 18, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-61156
Reason
After investigation of the returned product, it was confirmed that particulate may be generated when the tip of the needle pushes through the rubber septum of the vial. This presents a potential safety risk of a particulate being injected into a patient, and while remote, a potential risk of significant harm exists.
Affected products
Medrad Intego PET Infusion System - Source Administration Sets
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
INT CSS
Companies
- Manufacturer
-
Bayer Medical Care Inc.
1 Bayer Drive
Indianola
15051-0780
Pennsylvania
UNITED STATES