Stopcocks may have punctures in the sterile blister packaging


Smiths Medical report “Smiths Medical is providing this Urgent Field Safety Notice to advise its customers of a Field Safety Corrective Action for MedfusionTM Stopcocks. Smiths Medical is voluntarily taking this Field Safety Corrective Action with the knowledge of the relevant Regulatory Agencies. Smiths Medical has become aware of the potential for a small number of the MedfusionTM Stopcocks (“Stopcocks”) to have punctures in the sterile blister packaging. Since these blisters are used as a sterile barrier to maintain the device sterility, the potential risk is the device sterility may be compromised if not detected before use.

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