FDA-Device2025-03-12Class II
DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement
DeRoyal Industries Inc
Hazard
Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in inadequate suction and cause a delay in patient care.
Sold states
U.S.: IL, MN, NC, PA, and VA O.U.S.: N/A
Affected count
714 cases
Manufactured in
200 Debusk Ln, Powell, TN, United States
Products
DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1291-2025Don't want to check this manually?
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