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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00997-1
Product Name/Description Sydney IVF PVP (Used during microinjection techniques for reducing sperm motility to enable easier capture using a pipette)

Product Code: K-SIPV-200-5

Bulk batch number M0615061Z

Lot Numbers: K22948, K22752, K22551, K22825, K22625, K23042

ARTG number 132688
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 8/10/2015
Responsible Entity William A Cook Australia Pty Ltd
Reason/Issue This batch is being recalled as it was formulated with an excess of water, diluting the product outside the design specification. The batch met all of the release specifications, including Mouse Embryo Assay; however, the effect of this dilution is a loss of viscosity, and creation of a hypo-osmotic environment for the sperm. This may make it difficult for the embryologist to capture the sperm, and may lead to swelling of the sperm tail.
Recall Action Recall
Recall Action Instructions Cook Medical is advising users to any discard remaining stock. Cook Medical will replace affected stock with a credit or replacement. This action has been closed-out on 04/03/2016.
Contact Information 1800 777 222 - Cook Medical