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.Â
TGA Reference Number:Â RC-2023-RN-01069-1
Affected Product:Â AEROWASH Eyewash and Wound Irrigation (15 mL & 30 mL)
Affected Product Code:Â AW1000, AW1060, AW3010, AW3030
Batch Numbers:Â Please click here to view the affected batch numbers
ARTG Number:Â 159438
Intended Use:Â 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:Â 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.
To help us provide the correct information, please select your user type below.
This notice only applies to a limited number of batches of AeroWash manufactured in India between the dates of Jan 2023 and May 2023.
Please check the manufacture date and location and then if necessary the batch numbers of your individual ampoules. Also check the lot number / serial number of your first aid kits.
Download Batch Numbers (Excel) Download Batch Numbers in Customer Letter (PDF)
Checking For Affected Ampoules
If your ampoules match the examples below, they may be affected and should be checked against the batch number list.
Manufacturer Location: Made In India
Mfg Date: Between Jan 2023 and May 2023
Batch No: See list
The manufacturer location can be found on the ampoule label below the product name. The batch number can be found at the top of the ampoule label, near the product expiry.
Checking For Affected First Aid Kits
Lot Number: See list
Mfg Date (If Shown):Â Between Jan 2023 and May 2023
The lot numbers are typically located next to the expiry date on the case or contents list.
Non-Affected Batch Numbers
If your ampoules match the examples below, they are not affected and are safe to continue selling. There is no need to check the batch numbers on these ampoules.
If your batch number is not on the list, please complete the form below to acknowledge your receipt of this notice.
If your batch number is on this list please cease sale of the affected batch numbers and complete the form below acknowledge your receipt of this notice and determine your next course of action.
Further to the quarantine advice, all AEROWASH 15ml and 30ml ampoules are being recalled, and consumer refunds being offered.
We will issue a further recall update through your major wholesalers. Please wait until the RA process is available for stock you may hold and any stock that is returned to you.
If your stock was delivered from Aero Healthcare directly, please complete the form below to process your claim at the Customer Acknowledgement button below.
If you have first aid kits that contain the AEROWASH 15ml saline, this saline will require replacement before selling the kit to the retail consumer. We suggest that in the immediate future these ampoules are replaced at store level where possible, as replacement first aid kits will only be available late January.
Please be assured that this is a precautionary measure advised by the TGA and at this stage there has been no adverse reactions reported for this product. At this stage it is unclear when supply will resume on the AEROWASH eyewash and wound irrigation 15mL. No replacement stock is currently available.
This notice only applies to a limited number of batches of AeroWash manufactured in India between the dates of Jan 2023 and May 2023.
Please check the manufacture date and location and then if necessary the batch numbers of your individual ampoules. Also check the lot number / serial number of your first aid kits.
Download Batch Numbers (Excel) Download Batch Numbers in Customer Letter (PDF)
Checking For Affected Ampoules
If your ampoules match the examples below, they may be affected and should be checked against the batch number list.
Manufacturer Location: Made In India
Mfg Date: Between Jan 2023 and May 2023
Batch No: See list
The manufacturer location can be found on the ampoule label below the product name. The batch number can be found at the top of the ampoule label, near the product expiry.
Checking For Affected First Aid Kits
Lot Number: See list
Mfg Date (If Shown):Â Between Jan 2023 and May 2023
The lot numbers are typically located next to the expiry date on the case or contents list.
If your batch number is not on the list, please complete the form below to acknowledge your receipt of this notice.
If your batch number is on this list please cease sale of the affected batch numbers and complete the form below acknowledge your receipt of this notice and determine your next course of action.
Download Batch Numbers (Excel) Download Batch Numbers in Customer Letter (PDF)
Checking For Affected Ampoules If your ampoules match the examples below, they may be affected and should be checked against the batch number list. Manufacturer Location: Made In India Mfg Date: Between Jan 2023 and May 2023 Batch No: See list
The manufacturer location can be found on the ampoule label below the product name. The batch number can be found at the top of the ampoule label, near the product expiry.
Checking For Affected First Aid Kits Lot Number: See list Mfg Date (If Shown):Â Between Jan 2023 and May 2023
The lot numbers are typically located next to the expiry date on the case or contents list.
Non-Affected Batch Numbers If your ampoules match the examples below, they are not affected and are safe to continue selling. There is no need to check the batch numbers on these ampoules.
If your batch number is not on the list, then no further action is required and all other batch numbers are still considered safe to use.
If your batch number is on the list please dispose eyewash in your general waste & contact your place of purchase if a replacement/refund is needed.