Recall of Coloplast's Alterna(R) Sterile Post-Operative Ostomy Bags Due to Sterility Problem
7/28/2011 8:17:03 AM
Hong Kong (HKSAR) - After assessing a notification from a local medical device supplier, Coloplast (Hong Kong) Ltd, about its proposal to recall one of its product Alterna ® Sterile Post-Operative ostomy bag from consumers on sterility ground, the Department of Health (DH) endorsed the action. Coloplast, the manufacturer of the device under recall, found during routine product sterility test that a lot has failed. Investigation reveals that the failed lot of product was sterilised after January 2010, when the sterilisation process was moved over to a new site. Thus, Coloplast decided to conduct a recall of all products sterilised at the new site, though no report of any adverse incident arising from the use of ostomy bags produced in the new site has been received worldwide.