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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00800-3
Product Name/Description PCA Empty Sterile vials with injector. (Intravenous fluid container).

List Number: 060210403

ARTG number: 166111
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 10/08/2012
Responsible Entity Hospira Pty Limited
Reason/Issue There have been reports of leaking injectors on the empty sterile vial. Hospira's investigation concluded that injectors had a manufacturing defect in the promixal 'adhesive well' area due to a weak adhesive bond. The injectors accompanying the empty sterile vials may have an increased risk of leaking, particularly during the filling process.
Recall Action Recall for Product Correction
Recall Action Instructions The sponsor is providing work around instructions to mitigate the risk.
Contact Information 1300 046 774 - Hospira Customer Service