URGENT RECALL NOTICE (2 June 2023) Mask Only
Size 2 Mask (Toddler/Paediatric) Besmed
Model PN-0117, Lot Number MO14030303
Model PN-0117, Lot Number MO14030303
Update: 25 August 2023 - we believe that all affected masks have now been recalled and replaced. If you are concerned at all about a mask you have, please read below and/or contact us on 1300 890 345.
Original Story, 2 June 2023:
LifeVac Australia, after consultation with the Therapeutic Goods Administration (TGA), is conducting a recall of the above Paediatric Face Mask. Due to a packing error, a small number of an older production mask were included in a batch of masks for sale with the LifeVac device. The affected mask has a smaller outside diameter of the inlet port than specified; that does not engage tightly in the LifeVac suction device and may dislodge in operation and therefore being unable to create sufficient suction to remove an upper airway obstruction.
Action
Whilst the supply error has been rectified there are a small number of masks (<30) that were in circulation that may be affected.
Customers should inspect the masks in their kit for a mask/s with the lot number as specified.
If a defective mask is identified, it should be discarded immediately, and contact made with LifeVac Australia for an immediate replacement by completing the form on the Mask Recall Notification page on this site.
In the meantime, the No.3 mask intended for older children can be used as an effective replacement whilst waiting for a replacement mask in case of a choking emergency as this mask will fit most face sizes and a seal can be achieved.
Statement of Non-compliance
This recall does not affect any other mask sizes or Lot Numbers of or any other LifeVac Australia products. The affected masks may be contained in kits distributed between the following dates only: on or after the 28-March-2023 and prior to 02-June-2023.
Replacement Stock
The replacement stock for the affected No.2 Paediatric Mask is currently available. For further information please call LifeVac Australia on 1300 890 345.
Original Story, 2 June 2023:
LifeVac Australia, after consultation with the Therapeutic Goods Administration (TGA), is conducting a recall of the above Paediatric Face Mask. Due to a packing error, a small number of an older production mask were included in a batch of masks for sale with the LifeVac device. The affected mask has a smaller outside diameter of the inlet port than specified; that does not engage tightly in the LifeVac suction device and may dislodge in operation and therefore being unable to create sufficient suction to remove an upper airway obstruction.
Action
Whilst the supply error has been rectified there are a small number of masks (<30) that were in circulation that may be affected.
Customers should inspect the masks in their kit for a mask/s with the lot number as specified.
If a defective mask is identified, it should be discarded immediately, and contact made with LifeVac Australia for an immediate replacement by completing the form on the Mask Recall Notification page on this site.
In the meantime, the No.3 mask intended for older children can be used as an effective replacement whilst waiting for a replacement mask in case of a choking emergency as this mask will fit most face sizes and a seal can be achieved.
Statement of Non-compliance
This recall does not affect any other mask sizes or Lot Numbers of or any other LifeVac Australia products. The affected masks may be contained in kits distributed between the following dates only: on or after the 28-March-2023 and prior to 02-June-2023.
Replacement Stock
The replacement stock for the affected No.2 Paediatric Mask is currently available. For further information please call LifeVac Australia on 1300 890 345.
Identification
The affected mask can be easily identified by checking the part number PN-0117 and the Lot Number M014030303. If the packaging has been removed the mask can be test fitted into the LifeVac device, an affected mask will not engage (too loose) and fall out. A compatible mask will be a tight fit in the device.
The affected mask can be easily identified by checking the part number PN-0117 and the Lot Number M014030303. If the packaging has been removed the mask can be test fitted into the LifeVac device, an affected mask will not engage (too loose) and fall out. A compatible mask will be a tight fit in the device.
