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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01195-1
Product Name/Description Bayer Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System [Catalogue Number INT CSS]

Multiple batch numbers affected

ARTG Number: 154205
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 7/12/2015
Responsible Entity Imaxeon Pty Ltd
Reason/Issue Bayer Medical Care Inc. has identified that certain batches of the Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System may contain out-of-specification saline tubing and/or solvent occluding the Radio Pharmaceutical (RP) tubing.

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.

Although unlikely, these situations may lead to procedure delay, false negative result due to incomplete dose, inaccurate dose reporting in the patient record, overdose of RP delivered and in rare situations additional radiation exposure for the operator.
Recall Action Recall
Recall Action Instructions The sponsor Imaxeon is advising the users to inspect stock and quarantine the affected units prior to their return to the sponsor. There may be a delay in replacing the affected stock due to limited new inventory. This action has been clsoed-out on 29/08/2016.
Contact Information 1800 633 723 - Imaxeon