The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning Rusch Belly Bag Urine Collection Bag with Hip Belt [Model and part no.: Belly Bag 1000mL B1000, Belly Bag with 24inch Drain B1000CT, Belly Bag with Sample Port B1000P], manufactured by Teleflex Medical.
The manufacturer has issued a voluntary recall for the above products as the packaging may be compromised, and therefore the sterility of the product cannot be guaranteed. If non-sterile products are used, there is a possible risk of infection.
The manufacturer requests that medical staff to check their inventory for product within the scope of this field action. They should cease use and distribution of the affected product; and to quarantine immediately and return the affected product to Teleflex for replacement. They also advises distributor of the affected products to the field safety notice to all of their customers.
For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON252005
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 5 April 2013