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Recall Observatory FDA recall evidence

Device product

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

Z-1291-2025

January 31, 2025

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 96261
Status
Ongoing
Classification
Class II
Quantity
714 cases
Official record key
device-enforcement:Z-1291-2025

Official wording

Reason: 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.

Code information: 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

Distribution pattern: U.S.: IL, MN, NC, PA, and VA O.U.S.: N/A

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.