It has come to our attention that The Health Canada has issued a Type I Recall to remind healthcare providers and patients that Painsmart IOD, 6000 CMS and 4000 CMS (Ambulatory infusion pumps), which are manufactured by Zevex Inc. (also traded as Moog Medical Devices Group), may give an inaccurate infusion.
The accuracy of infusion with a syringe varies widely depending on the medication and stiction between the barrel and plunger of individual syringes. The effects of the variables have made the accuracy difficult to evaluate as each condition produces differing effects from the syringe variables. Therefore, Zevex is not confident in providing accuracy percentages for syringes as they may be misleading if the application conditions are also considered. As a result, the labeling will be modified to indicate the accuracy of delivery from a syringe cannot be guaranteed.
For details, please refer to the Health Canada website:
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_oct-dec_2011-eng.php
If you are in possession of the affected product, please contact your supplier for necessary actions.