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FDA (Device enforcement)Recalled 2025-01-31class ii

DeRoyal Industries Inc: DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Mo

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.

Details from the source

Reason for recall: 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. Distribution: U.S.: IL, MN, NC, PA, and VA O.U.S.: N/A Quantity: 714 cases Lot/code info: 71-C5100NS Bulk Roll Suction Connector Tubing UDI-DI code: 00749756578738 Lot Number: CNWKD04-04 71-C6100NS Bulk Roll Suction Connector Tubing UDI-DI code: 00749756578851 Lot Numbers: CNWKD04-04 CNWKD04-05 CNWKD04-10 CNWKD09-08 71-C7100NS Bulk Roll Suction Connector Tubing UDI-DI code: 00749756578967 Lot Numbers: CNWKD04-06 CNWKD04-07

UPC codes

00749756578738, 00749756578851, 00749756578967

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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