Important customer notice Field Safety Notice

Urgent Field Safety Notice Westcott Medical

• Date:08/02/2012
• Product area:Clinical |

NHS Supply Chain wishes to notify customers of an urgent field safety notice issued by Westcott Medical relating to the SAE-Flo MD Extension Set with Y Connector following reports of an apparent milky discolouration of the tubing at certain points along the length of the set. Lot number 2011-1510 only.

This is caused by delamination of the inner polythene tube from the outer PVC sheath during manufacture.

NPC: FSB1176
MPC: WEPCA200AY
Description: Sae Flow MD extension set with Y connector
Lot No: 2011-1510
UOI: Pack of 32 

There is a slight risk that air bubbles present in the set during priming may not be seen and flushed out, although it should be emphasised that any air bubbles will still be visible if the set is inspected thoroughly during set up. There is no indication at this stage of any increased risk of leakage from or into the set as both the inner PE tube and the outer PVC sheath retain their integrity.

This is an advisory notice of which the MHRA are aware.

See attached FSN 120101 for full details

Users should be reminded to inspect the set on removal from the packaging and again thoroughly for air bubbles during priming. Any milky discolouration in the tubing should be immediately apparent. Any affected sets should not be used and should be put on one side for replacement by the manufacturer.

As a precautionary measure and at the discretion of the trust sets of the affected lot number may be returned to NHS Supply Chain for credit. If this is your chosen option please contact your NHS Supply Chain Customer Service Advisor, quoting return to supplier reference 51, code 7 return. All products to be back at NHS supply Chain Depots no later than Friday 02 March 2012.

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