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AEROBURN PE Burn Sheets

Recall - Potential sterility breach

19 April 2022

AEROBURN PE Burn Sheets are coverings used to protect burn patients during transportation to a burn centre or hospital. The TGA has received reports from Aero Healthcare that the seals on the product packaging may have been damaged during transit. This can result in contamination of the product which may lead to infection.

AEROBURN PE Burn Sheets 60cm x 90cm are supplied individually or as part of a first-aid kit. All batches supplied between September 2018 and March 2022 are subject to this recall.

What should I do?

Consumers and Healthcare Professionals are advised to check their supply (including first aid kits) for AEROBURN PE Burn Sheets 60cm x 90cm from the following affected batches/kits:

Affected batches: 186090, 196090, BS690323, BS690916, BS690D14, BS690N08, BS690O10, BS691302, BS691321, BS691625, BS691720 and BS691810

Affected first aid kits: AAS060+, AFAKBNA, AFAKBNAR, AFAKBNB, AFAKBNBR, AFAKBNC, AFAKHFA45S, AFAKMODB, AFAKMODM4, AFAKMODM4-COM, AFAKMODM4-COMF, AFAKMODS4, AFAKMODS4-COM, ALMBU, ALMBUP, ALSMBU, C.AFAKABC, CPMBUR3, EFAPBDR, FAISB1, HRAFTBK, RSWREFILL, RWWCIVS, SAPBURM, SSFTYP, SSGTSPK.

Inspect product in your possession. If any of the affected batches are found, inspect the sealing edge indicated by the arrow (opposite the 'peel to open' edge).

picture of packaging
image of broken packaging

If the pouch is damaged or the seal is broken, do not use the product and call the customer service line to arrange a replacement when available.

If the pouch seal is undamaged the product may be used safely.

If you have any questions or concerns, contact the Aero Healthcare Customer Service Team on 1800 628 881 or your health professional.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.