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Quality & Innovation in Healthcare
 

FIELD SAFETY CORRECTIVE ACTION (FSCA) – PRODUCT RECALL 37717 

Posted by   on 04-October-2016 
FIELD SAFETY CORRECTIVE ACTION (FSCA) – PRODUCT RECALL 37717

Product Code: 1188.15 (FSB393) - LECTROGUARD

Lot/Batch Numbers:230115EE, 010615EE, 071015EE

The manufacturer has identified a white deposit on the outer surface of some devices.  The white deposit is an excess quantity of an anti-UV additive. 

The extension tubing of the device is manufactured from two layers of polyethylene.  The outer layer contains an anti-UV additive to protect light sensitive drugs during infusions.  The inner layer of the extension tubing does not contain the additive and will act as a barrier, preventing contact between the anti-UV additive and the fluid pathway.  As patient safety is of paramount importance to Vygon and, as a precaution, we are recalling the affected batch numbers.

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