PRA number
Published date
Product description
MIC Gastrostomy Feeding Tubes
Product codes: 8100-18, 8100-20, 8100-24, 8110-24, 8110-20, 8100-16LV, 8110-22, 8650-22, 8200-18 and 8200-12LV
Lot numbers: 30132705, 30136831, 20065468, 20060902, 30135306, 20064000, 30125515, 30109195, 30116636, 20018684, 30118459, 30111735, 30121125, 30115830, 30124026 and 30111728
ARTG 260222
(Avanos Medical Australia Pty Ltd - Button, gastrostomy)
ARTG 248294
(Avanos Medical Australia Pty Ltd - Tube, feeding, jejunostomy)
This recall has been expanded to include ARTG 248294, ACT, additional product codes, lot numbers from 6 December 2021.
Reasons the product is recalled
The Instructions For Use leaflet was not supplied with the product.
The Instructions For Use provide important safety information for the user.
The hazards to consumers
Consumers who have been supplied the products without the Instructions For Use may not be aware of important information about the use of the product. This poses an increased risk of adverse health complications.
What consumers should do
Consumers will be contacted by Avanos Medical and provided with a link to an electronic copy of the Instructions For Use and, on request, a Instructions For Use leaflet.
For more information, consumers should contact their healthcare provider, or contact Avanos Medical on 1800 101 021 or CustomerService.ANZ@avanos.com
Supplier
Traders who sold this product
Health facilities and distributors
Where the product was sold
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.