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TGA Action ID	RC-2026-RN-00179-1
Type of Product	Medical Device
Product Name/Description	Various BVM Resuscitator Multiple Products Product Codes/Lot Numbers: 7150000, 7151000, 7151001, 7151006, 7152000, 7152003, 7152005, 7152060, 7152507, 7153000, 7153006, 7153502, 7153506, 7154000, 7155000, 7156000
ARTG Number	225855
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Following customer report form the market and subsequent thorough inspection and analysis of internal stock, Intersurgical have identified that some products have been manufactured without one of the valves at the rear of the BVM Resuscitator. This does not have an impact upon the ability to provide adequate ventilation but does have an impact upon the ability to deliver the higher Oxygen concentrations which may result in a negative impact upon clinical outcome during CPR.
Instructions for Customers/Users	Customers are to: 1. Inspect stock on hand and immediately quarantine affected stock of listed lot numbers to prevent further use. 2. Identify any potentially affected products from the affected codes and lot numbers listed above. 3. All users must perform a thorough visual inspection before use of the products and lot numbers listed above, to confirm both one-way valves are present. 4. Return any affected sample(s) identified, to Intersurgical Australia immediately for replacement stock. This action has been finalised on 23/6/2026.
Action Commencement Date	16/03/2026
Responsible Entity	Intersurgical Australia Pty Ltd
Contact Information	02 8048 3300 - Intersurgical