Background Information Or Related Documents:
ConvaTec are recalling various models of Suction catheters, Gastro-enteral Tubes, Intermittent Urology Catheters and Urine Drainage Bags. This product recall is being conducted after internal testing revealed the potential for a breach in the sterile barrier which could lead to a patient being exposed to infectious agents and developing an infection. ConvaTec are advising these products are not used and are quarantined to await collection from the distributor.
This recall was originally initiated in July 2018, at that time only Suction Catheters and Gastro-enteral Tubes were included in the scope of the recall. In September, after further testing by the manufacturer, the scope of the recall was expanded to include specific product codes of Suction Catheters, Gastro-enteral Tubes, Intermittent Urology Catheters and Sterile Urine Drainage Bags.
The HPRA are issuing this safety notice at this time, as we have only recently been made aware that the Irish market is affected by this recall and that a significant number of these devices were provided to the market through third-party distributors. various supply routes. Please refer to both accompanying FSNs as only specific product codes of the below devices are being recalled.
- Unomedical Nelaton catheters/Nelaton catheters
- Unomedical Female catheters/Female catheters
- Unomedical Tiemann catheters/Tiemann catheters
- Unomedical Suction catheters (Ideal, Optimal, Mully, Coude, Vacutip)
- Unomedical Feeding tubes
- Unomedical Purifeed Feeding tubes
- Unomedical Duodenal tubes
- Unomedical Stomach tubes
For full details of affected devices and details of how to identify devices, please read both FSNs from ConvaTec as they each contain different product codes.
FSN 1
FSN 2
Updated FSN
Download full Safety Notice