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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00246-1
Product Name/Description	NF02L ENFit Double Lumen Replogle Tube 10FR Product code: NF02L Batches numbers: 19I09004, 21F18002, 23C03045, 23C03046 ARTG 336611 (Intermed Medical Pty Ltd - Tube, nasogastric)
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	26/03/2024
Responsible Entity	Intermed Medical Pty Ltd
Reason/Issue	Intermed Medical Pty Ltd is recalling batches 19I09004, 21F18002, 23C03045, 23C03046 of the ENFit Double Lumen Replogle Tube due to an established design problem which has the potential to impact the health and safety of patients. The problem pertains to a reasonable probability of holes in the nasogastric tube, which can pose a risk of aspiration leading to respiratory complications. Potential hazards are patient acute respiratory deterioration (distress, chocking), discomfort and delay of treatment for oesophageal atresia, death.
Recall Action	Recall
Recall Action Instructions	Customers are to identify all affected batches (19I09004, 21F18002, 23C03045, 23C03046), and stop using the products immediately. In order to return the devices to Intermed, customers must complete and return the Acknowledgement Form.
Contact Information	1300 123 633 - Regulatory Affairs & Quality Assurance