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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00834-1
Product Name/Description	Multigate Custom Procedure Packs Multiple Product Codes and Lot numbers ARTGs: 163168, 163169, 163250, 163251, 163252, 163253, 163255, 163256, 164293, 164294, 168756, 169753, 223714, 307405
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	25/09/2024
Responsible Entity	Multigate Medical Products Pty Ltd
Reason/Issue	In August 2024, Multigate received a customer report indicating that a white powder had been found on the surface of a kidney dish component included in a specific custom procedure pack. In response to this complaint, 40 packs of this specific item were returned. A second complaint from the same customer followed in September for a different procedure pack and a further 19 packs were returned with the same problem exhibited on the kidney dish surface for dishes contained within the 19 packs. Investigations following these two complaints have identified that the white powder is the product of a defective manufacturing process where an excessive volume of slip additive was used in the moulding of a batch of clear kidney dishes. The slip has leached out of the kidney dish after the completion of the sterilisation process for the packs in which it was used, leaving the kidney dishes coated with excess residue.
Recall Action	Recall
Recall Action Instructions	Customers are to immediately identify, quarantine all unused affected product in their inventory, and return the customer confirmation form to organise replacement of affected product.
Contact Information	1800 023 420 - Customer Service Team