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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00606-1
Product Name/Description	Medline procedure packs containing Unomedical Suction Tubing (Sterile and Non-sterile) Sterile Codes: 530.25.200, 530.25.300, 530.25.450, 530.25.600, 530.25.800, 530.30.200, 530.30.300, 530.30.450, 530.30.600, 533.30.300 Non-sterile Codes: 533.25.050, 533.25.100, 533.25.150, 533.25.200, 533.25.300, 533.25.450, 533.25.600 Multiple Batches ARTG Numbers: 137961 (Sterile) & 204281 (Non-sterile)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	3/07/2015
Responsible Entity	Medline International Two Australia Pty Ltd
Reason/Issue	An internal assessment of ConvaTec’s product complaints has confirmed that these devices are not meeting their expectations or those of our customers. Specifically, the connector part for application to the suction devices in these LOTs, has failed to meet its required reliability. Suction Tubes are intended to connect a suction device, such as a suction catheter or suction handle, to a vacuum unit. Suction Tubes are equipped with multi-purpose connectors that are designed to fit many suction devices and outlets. The connector parts of the specified LOTs have a higher probability to crack once applied to suction devices outlets.
Recall Action	Recall
Recall Action Instructions	Medline is requesting end users to remove and discard the Unomedical Suction Tubing from the procedure pack at the time the scrub nurse prepares for the surgery. This action has been closed-out on 15/08/2016.
Contact Information	1800 110 511 - Customer Service Team