Coloplast found during routine product sterility test that a lot of samples of its Alterna ® Sterile Post-Operative ostomy bag failed.
Investigation revealed 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. DH also had not received any such notification locally.
The models under recall are 12808, 12810 and 12818, all with expiry date on January 1, 2013 or later.
Alterna ® Sterile Post-Operative ostomy bag is used for collecting output from stoma - an opening created on the abdomen after bowel or urinary tract surgery in order to divert faeces or urine respectively.
Do you know more about this story? Contact us anonymously through this link.