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Unomedical Sterile Urine Drainage Bags

Notice type: Recall

Date: 19/07/2011

  

Product name or type:
Unomedical Sterile Urine Drainage Bags

Reference:
IMB Safety Notice: SN2011(18)

Manufacturer Or Supplier:
Unomedical A/S

Target Audience:
Theatre and Nursing Staff 
Procurement Managers 
Nursing Managers 
Hospital Managers / CEOs 
Clinical Directors 
Risk Managers 
Medical Device Distributors 
Clinical / Biomedical Engineers 
Pharmacists 
Members of the Public 

Problem Or Issue:
Unomedical A/S has become aware that in certain sterile urine drainage bags, there is potential that the connector between the catheter and bag may be blocked.

Background Information Or Related Documents:
Unomedical A/S has confirmed that this issue is limited to specific model and lot numbers (see attached field safety notice). If this defect is present, it is possible that urine would not drain into the bag, which may result in urine retention in the bladder. Urine retention may necessitate medical intervention additional to routine care. The bag would need to be changed more often and the risk of developing an infection, if standard of care were neglected, may increase. 
Unomedical A/S has published a field safety notice (FSN) and has undertaken a recall of the affected product lots.

Unomedical Sterile Urine Drainage Bags Document

Actions To Be Taken:
The manufacturer and the distributors of this device in Ireland have been unsuccessful in their attempts to locate all devices affected by this field safety corrective action (FSCA). 
The IMB advises that users: 

• Follow the manufacturer’s recommendations as outlined in the attached FSN. 
• Identify the affected devices in your facility and contact the manufacturer to arrange for return.

Further Information:
Enquiries to the manufacturer should be addressed to: 

Sara Collins 
Customer Service Supervisor 
Unomedical Ltd 
First Floor, Unit 3 West Wing 
Brooklands, Moons Moat Drive 
Redditch, Worcestershire 
B98 9DW 
United Kingdom 
Telephone: +44 1527 583622 
Fax: +44 1527 591198 
E-mail: sara.collins@convatec.com 

All adverse incidents relating to a medical device should be reported to the: 

Health Products Regulatory Authority
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 
Telephone: +353-1-6764971 
Fax: +353-1-6344033 
Website: www.hpra.ie 


Please click here to download a PDF Version of the Safety Notice: SN2011(18)

SN201118_UnomedicalSterileUrineDrainageBags_FSN_V10743

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