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Health product recall

MEDRAD INTEGO PET INFUSION SYSTEM - MAIN (2016-05-31)

Starting date:
May 31, 2016
Posting date:
June 13, 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-58844

Affected products

A. MEDRAD INTEGO PET INFUSION SYSTEM - MAIN

Reason

In January 2016, a customer complaint reported a mismatch between the prescribed dose value displayed on the screen and the prescribed dose value printed by the printer. The dose activity infused was as intended and printed correctly.

Affected products

A. MEDRAD INTEGO PET INFUSION SYSTEM - MAIN

Lot or serial number

Serial Number 300030

Model or catalog number

INT SYS 200

Companies
Manufacturer
Bayer Medical Care Inc.
1 Bayer Drive
Indianola
15051-0780
Pennsylvania
UNITED STATES