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Quality & Innovation in Healthcare
 

Field Safety Corrective Action (FSCA) – Product Recall 

Posted by Vygon (UK) Ltd  on 25-January-2017 
Field Safety Corrective Action (FSCA) – Product Recall

Product Code: SW204501 Lot Number: P8096 Product Code: SW204501 Lot Number: P8251 Product Code: SW223501 Lot Number: P8098 Product Code: SW224501 Lot Number: P8097

Product Code: SW204501 Lot Number: P8096

Product Code: SW204501 Lot Number: P8251

Product Code: SW223501 Lot Number: P8098

Product Code: SW224501 Lot Number: P8097

The manufacturer (VIGMED) has identified that the catheter material (FEP - Fluorinated Ethylene Propylene) in combination with beta-sterilization is more sensitive to repeated kinking than similar vascular catheters of other material and/or sterilization method. Repeated kinking of a beta-sterilized FEP catheter can, in rare cases, result in catheter breakage and may therefore need to be removed by surgical intervention.

Please find a copy of the Field Safety Notice (FSN) and the fax/email back form through this link here.

For more information please use the Contact Form