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The Department of Health (DH) today (May 23) endorsed the voluntary recall of three batches of Braunoderm iodine solution by its German manufacturer, B. Braun Medical AG, as less than the specified amount of the active ingredient, iodine, was detected in the products through ongoing in-house monitoring.
DH was notified of the move by the product's local supplier, United Base (Hong Kong) Ltd. The latter reports that regular stability analysis by the product manufacturer reveals that the level of available iodine in some batches falls slightly under the shelf-life specification before the expiry date is reached.
The exact details of the three batches under global recall are:
a) Braunoderm Ungef Variofl 'DE' 1000ml
(Article No.: 3881156, Batch No.: 0253M14)
b) Braunoderm Ungef Spruehfl 'DE' 250ml
(Article No.: 3881105, Batch No.: 0253M14)
c) Braunoderm Ungef Spruehfl 'DE' 1000ml
(Article No.: 3881105, Batch No.: 0103M11)
In Hong Kong, only the second of the batches listed above has been imported by United Base for distribution to public and private hospitals, dialysis centres and nursing homes.
"Although B. Braun assesses that the effectiveness of the disinfectant is unlikely to be compromised as the insufficiency is only marginal, to be prudent, DH endorses the recall, especially as we understand that in Hong Kong the product is also used by hospitals and dialysis centres to disinfect haemodialysis equipment besides for skin disinfection," a DH spokesman said.
"Given that renal patients are chronically ill and often also immune-compromised, their safety cannot be overlooked," the spokesman added.
It is reassuring that so far DH has not received any report of any adverse event related to the affected product. All healthcare institutions that have received the affected product have been approached by United Base for the recall.
United Base (Hong Kong) Ltd. has also set up the hotlines 2959 6138 and 9859 0231 to answer related enquiries.
The spokesman urged individual customers and healthcare providers who still have the affected disinfectant in hand to stop using it immediately and to choose substitutes from alternatives available on the market.
He reaffirmed that DH will continue its investigation, closely monitor the recall and seek legal advice on suspicion of any breach of the law.
Ends/Monday, May 23, 2011
Issued at HKT 19:05
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