PRA number
2019/17748
Published date
Product description
Hollister Urostomy bag
ModermaFlex Convex Flextend Tape Bordered Urostomy V2 Tnsp 25mm PS
Product Number: 2979125
Lot Number: 9C282
ModermaFlex Soft Convex CeraPlus Tape Bordered Urostomy V2 VO 30mm PS
Product Number: 59830
Lot Number: 9F253
ModermaFlex Soft Convex CeraPlus Tape Bordered Urostomy V2 UClr 15-38mm CTF
Product Number: 59901
Lot Number: 9F073
ARTG: 296216
(Liberty Medical Pty Ltd - Bag, urostomy, one-piece)
ModermaFlex Convex Flextend Tape Bordered Urostomy V2 Tnsp 25mm PS
Product Number: 2979125
Lot Number: 9C282
ModermaFlex Soft Convex CeraPlus Tape Bordered Urostomy V2 VO 30mm PS
Product Number: 59830
Lot Number: 9F253
ModermaFlex Soft Convex CeraPlus Tape Bordered Urostomy V2 UClr 15-38mm CTF
Product Number: 59901
Lot Number: 9F073
ARTG: 296216
(Liberty Medical Pty Ltd - Bag, urostomy, one-piece)
What are the defects?
There is a possible weakening of the Urostomy bag pouch film.
What are the hazards?
Weakening in the pouch film could lead to film seal separation or film bursting during use, resulting in injury to the user.
What should consumers do?
Liberty Medical is advising users to inspect stock and discard units from the impacted lots. The SKU/Lot Number is printed on one of the side labels on each box.
Consumers are advised to contact their distributor for a product replacement.
For further information, contact Liberty Medical on 1800 880 851.
Consumers are advised to contact their distributor for a product replacement.
For further information, contact Liberty Medical on 1800 880 851.
Supplier
Liberty Medical Pty Ltd
Where the product was sold
New South Wales
Victoria
Western Australia
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.