Recall issued for Medicina Ltd enteral feeding devices
March 25 2015
The MHRA has issued a recall affecting a range of enteral feeding devices and accessories originating from Medicina Ltd. Included in the recall are syringes, plasters, dressing and rectal straws.
Problems have arisen as there is a risk of infection from using the gastrostomy button feeding kits, says the MHRA. In addition, the CE marking is invalid as the safety and performance of all the devices listed has not been properly evaluated.
The full list of items being recalled is:
• MBXX/YY Low Profile Gastrostomy Button ‘Feeding Kits’ FSN (issued December 2014)
• GW01 Gastrostomy Guide Wire FSN (issued October 2014)
• FBXXXX Flexi Feed Container FSN (issued November 2014)
• MEDXXXM Superlock Drainage Bag FSN (issued November 2014)
• OTCB Oral Tip Cap Bulk (non-sterile) FSN (issued March 2015)
• GC01 Blue Gastrostomy Clip FSN (issued March 2015)
• P700 Purple Syringe Pump FSN (issued March 2015)
• P900 Enteral Syringe Pump FSN (issued March 2014)
• IVL60 Luer Lock IV Syringe FSN (issued November 2014)
• IVS60 Luer Slip IV Syringe FSN (issued November 2014)
• IVL01 1ml Luer Lock IV Syringe FSN (issued November 2014)
• IVL60 (INS) 60ml Luer Lock IV Syringe for Insulin FSN (issued October 2014)
• MRXX Manually Retractable Safety Syringe, including MR05L 5ml Manually Retractable Safety Syringe with Extended Barrel and MR01/27 1ml Manually Retractable Safety Syringe with 27G Needle FSN (issued November 2014)
• DSXX Silo Dressing FSN (issued October 2014)
• KDXX Keyhole Dressing FSN (issued November 2014)
• NS01 Nasogastric Plaster (Nasal Strip) FSN (issued December 2014)
• NS05 Nasogastric Fixation Kit FSN (issued December 2014)
• SD02 Ace Stopper Dressing “Grip-Lock” FSN (issued March 2015)
• RCXXX Rectal Straw FSN (issued November 2014
Further information about each product is given in the MHRA recall notice.
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