F&P HC405A recall in Australia

Peterau · Post by **Peterau** » Sat Jan 13, 2007 4:22 pm

For those that may have not received the recall notice.

A "recall for correction" notice for the Fisher & Paykel HC405A mask has been issued in Australia. According to the notice the complete list of masks experiencing the problem is:

HC401A
HC401U
HC405A
HC406A
HC407A
HC407NIVB
HC431A
HC431B
HC431NIVB
HC451U
HC452A
HC452B
HC452NIVB
HC481A

The problem is with that "the plastic tabs incorporated into the connector components of these CPAP mask may break off if they are not cleaned in accordance with the Instructions for Use". If a tab breaks off in use "it may enter the CPAP system air path and there is a remote possibility that the broken tab may then enter the patient's upper airway".

The solution is to replace the connector piece with one of different design which does not have a tabbed locking rings, but instead has a continuous locking ring.

Masks manufactured since April 2006 have the new connector piece.

The recall has been made after consultation with the Therapeutic Goods Administration, and is being done voluntarily by Fisher & Paykel.

Peterau

Doodeedoo · Post by **Doodeedoo** » Sun Jan 14, 2007 10:16 am

See viewtopic.php?t=15944