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 |
|
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 |