AeroWash Recall Response Card - ARTG: 159438 - TGA Reference: RC-2023-RN-01069-1

After consultation with the Therapeutic Goods Administration (TGA), Aero Healthcare is conducting a Medical Device Recall action and notification of certain batches of AeroWash Eyewash and Wound Irrigation (15mL and 30mL). Please note you will not be affected by this recall if you have not received these batches during 2023. 

TGA Reference Number: RC-2023-RN-01069-1

Affected Product: AEROWASH Eyewash and Wound Irrigation (15 mL & 30 mL)

Affected Product Code: AW1000, AW1060, AW3010, AW3030

Batch Numbers: Please click here to view the affected batch numbers

ARTG Number: 159438

Intended Use: A solution, typically saline, used to assist in clearing and cleaning a site during a medical/surgical procedure (e.g., flushing the ocular area during eye surgery).

Problem: The TGA has been made aware of possible contamination of Sodium Chloride 0.9% solution products manufactured by Legency Remedies Private. This is due to reported cases of Ralstonia pickettii in multiple jurisdictions. While investigations into this continue we are recalling the identified batches of sodium chloride solution as a precaution.

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