Defect: Gentec 286MB 25LY2A click-style oxygen regulators – SIS seal collar is removable (update)

A product defect correction has been issued in Australia for Gentec product code 286MB 25LY2A, click-style 25L/minute medical oxygen regulators with two sleeve-indexed safety (SIS) self-seals and one hose barb, distributed by Tesuco Pty Ltd.

The oxygen-specific SIS self-seal collars on this device prevent any gas but oxygen being connected to the regulator. This product is being recalled because it has been discovered that the seal collars can be unscrewed by hand in certain circumstances, making it possible for a wrong gas to be connected, with associated risks to patient safety.

The distributer has written to customers advising that they either:

• identify any devices with loose collars, and secure with high strength thread lock adhesive as described in the letter;

or:

• return devices to Tesuco for corrective action.

For more information, see the Therapeutic Goods Administration Australia recall listing.

Update 15 September 2022: The distributor has advised Medsafe New Zealand that the affected device batch has not been sold into New Zealand. However, Medsafe asks that users check any of these devices they may have for batch number 61K-21040054, and if found, report to Medsafe and to the supplier.