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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00185-1
Product Name/Description Sangofix set with hand pump (Blood/Solution Transfusion Set)

Article Codes: 4050192, 4050192H and 4050193

All Batch Numbers affected

ARTG Number: 137615
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 19/02/2016
Responsible Entity B Braun Australia Pty Ltd
Reason/Issue This recall is initiated due to incorrect information provided on the labelling. In the course of routine quality tests, it was discovered that Sangofix sets with hand pump contain DEHP (approx. 1.6% per set). The Sangofix sets, however, are labelled DEHP-free.
The mislabelling is limited to the affected article numbers as the DEHP containing hand-pumps are only used in the specified products
Recall Action Recall
Recall Action Instructions B. Braun is advising users to inspect stock and quarantine all units with the affected article codes. Affected stock can be returned to B. Braun and users will be issued a credit note. This action has been closed-out on 15/05/2017.
Contact Information 1800 172 182 - B.Braun Australia