NHS Supply Chain recall ref: 46
Ref: ICN 2011/390
14 November 2011
MDA Notice/Product Recall
Ref: MDA/2011/102
FDE054 Venturi Valve 60%
Lot number WL018147 only
NHS Supply Chain has received notification of a Medical Devices Alert MDA/2011/102 following an urgent Field Safety Notice issued by Lifecare Hospital Supplies Ltd.
Lifecare Hospital Supplies Ltd is recalling lot number WL018147 only of FDE054.
Description of Problem
It was found that on a small number of devices, the venture section was totally occluded which would therefore prevent oxygen from reaching the patient.
An intermittent fault in the moulding process has been identified and appropriate corrective actions have been implemented to prevent future occurrences.
All potential faulty batches have been identified and are listed in the attached Medical Device Alert. Please note the two other products on this alert have not been supplied through NHS Supply Chain.
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Please see below Medical Device Alert Ref: MDA/2011/102
Action Required
Inspect your inventory and Quarantine any affected lot numbers. Carry out the actions described in the manufacturers FSN, including sending any confirmation requests to the manufacturer. Lifecare Hospital Supplies Ltd will collect and replace affected lots directly please Email/Fax your completed response form to:
Mr Gino Ostacchini
Quality Assurance Department
Lifecare Hospital Supplies Ltd
Tel: 01279 414969
Fax: 01279 635232
Email: qaadmin@clement-clarke.com
Product Recall FDE054 Lifecare Hospital Supplies Ltd | Welcome to NHS Supply Chain
