FDA-Device2023-05-24Class II
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
Smiths Medical ASD Inc.
Hazard
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or specify the number of cycles the product can be reused on a single patient.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, New Zealand, and Hong Kong.
Affected count
47007 units
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breathing circuits
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1580-2023Don't want to check this manually?
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