06 Aug 2012
MEDICAL DEVICE ALERT
Ref: MDA/2012/054
06/08/12
SpeediCath complete intermittent urinary drainage catheter
(manufactured by Coloplast)
Multiple product codes and lot numbers
SpeediCath complete intermittent urinary drainage catheter is being recalled by Coloplast as the sterility of the catheters can not be guaranteed.
A Field Safety Notice was issued by Coloplast on 5 June 2012 about this recall however a recall has been issued by the MHRA because they can not be confident that the recall was actioned effectively.
SpeediCath complete intermittent urinary drainage catheter will not be available again until Coloplast can identify the cause of the problem.
The SpeediCath complete intermittent urinary drainage catheter should not be used.
Pharmacies need to identify the affected products as stated in the Field Safety Notice and contact Coloplast or your distributor for credit as detailed in the Field Safety Notice.
Pharmacies should identify and contact patients who have received the catheters and ask for any unused devices to be returned to the pharmacy.
Patients should be referred to their prescriber for advice on alternative catheters to use.
For further information contact Coloplast on 01733 368989 or email GB_Trade@coloplast.com.
