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Medrad Intego Pet Infusion System - Source Admini (2015-11-30)
- Starting date:
- November 30, 2015
- Posting date:
- February 1, 2016
- 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-56884
Affected Products
MEDRAD INTEGO PET INFUSION SYSTEM - SOURCE ADMINI
Reason
The inner diameter of the saline tubing is out of specification and may result in the system failing to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. The occluded SAS tubing may impair the priming function and prompt an "RP prime failed. Check SAS and vial installation, then reprime" error message.
Affected products
MEDRAD INTEGO PET INFUSION SYSTEM - SOURCE ADMINI
Lot or serial number
More than 10 lots, contact manufacturer
Model or catalog number
INT CSS
Companies
- Manufacturer
-
Bayer Medical Care Inc.
1 Bayer Drive
Indianola
15051-0780
Pennsylvania
UNITED STATES