Medical device recalls Moderate risk

DeRoyal Industries Inc recalls DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7…

Recall date
January 31, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1291-2025
FDA classification
Class II
Brand / firm
DeRoyal Industries Inc
Sold / distributed
U.S.: IL, MN, NC, PA, and VA O.U.S.: N/A

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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