Wednesday, 05 July 2017 14:54

Global Recall Of Oxygen Masks By British Authority

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The National Agency for Food and Drug Administration and Control has been notified that the British Medicines and Healthcare Products Regulatory Agency (MHRA) have announced the global recall of various High Concentration Oxygen Masks manufactured by ConvaTec and Unomedical. High Concentration Oxygen Masks are intended to deliver high concentration oxygen to patient airways.

Reason for recall

  •  Product reports confirmed that the devices are not meeting the desired expectation.
  •  In some cases, the tubing was found to be disconnecting from the oxygen mask, prior to use or during use causing disruption in oxygen supply.

The details of the affected batches are as follows;

Manufacturer’s Address: ConvaTec Limited, First Avenue, Deeside Industrial Park,

                                            Deeside, CH5 2NU, U.K.

Product Code / REF No. SAP Code Description LOT No's.
104MM 1302097 Rebreathing mask, Reservoir bag, with Tubing 105631

106MM

1702436

Oxygen Mask, Adult High Concentration Non-Rebreather 2.1m (7') Oxygen Tubing

100733,104106,104798,100721,109824

108-E 1300168 Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1m (7’) Oxygen Tubing

102766,102785,102726,102352,105451,

109186

108MM 1705302 Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1m (7’) Oxygen Tubing

100281,100709,100729,101923,103180,

103265,103691,103714,104104,105987,

110558

3226-E 1308753 Non-Rebreather Oxygen Mask, Pediatric High Concentration with 2.1m (7’) Oxygen Tubing 102727
3226MM 1307553 Non-Rebreather Oxygen Mask, Pediatric High Concentration with 2.1m (7’) Oxygen Tubing 100720,101141
3230MM 1302405 Non-Rebreather Oxygen Mask, Pediatric High Concentration with 2.1m (7’) Oxygen Tubing 104906,105181
9108MM 126152 Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1m (7’) Oxygen Tubing

100232,100694,100918,101639,101897,

103067,104846,104848,105453

       

Healthcare Provider’s Action

  • Healthcare providers in possession of these affected products should stop using them.
  • Healthcare providers and patients are encouraged to report adverse events associated with the use of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via This email address is being protected from spambots. You need JavaScript enabled to view it.

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Read 1883 times Last modified on Wednesday, 05 July 2017 15:02

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