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DeRoyal REF 71-C5100NS Tubing, Suction, Connector recallZ-1291-2025 · DeRoyal Industries Inc · initiated Jan 31, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from DeRoyal Industries Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

On 01/31/2025, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via email to customers informing them that bulk roll, non-sterile suction connector tubing products and lots which could possibly be defective. The inner diameter of the suction tubing connector, is 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. Customers are instructed to: 1) Identify affected product numbers in their inventory and place in quarantine to prevent further use. Destroy all product identified and complete the NOTICE OF RETURN FORM indicating all affected products found in their inventory. Return the completed form to DeRoyal via fax to 865-362-3716 or [email protected] no later than March 7, 2025. Complete and return the Notice of Return Form even if you no longer have any invenorty. 2) If affected products have been further distributed to other facilities or departments within customer's institution, customers should be notified of this recall. by either directly forwarding the recall notification and notify DeRoyal that you have done so, or you may provide us with the customer listing and we will contact them. 3) Delay in patient care could lead to serious adverse events. A patient may aspirate, requiring immediate suction to prevent life-threatening injury. Inadequate suction not identified by the clinician could increase infection risk. For questions regarding credit for the recall, contact Jennifer Marsh at [email protected] or by phone 865-362-6206 or email us at [email protected]. If customers prefer to receive replacement product, contact DeRoyal Sales Representative or contact Angie Schubert, Assistant Product Director, at [email protected].

Recall details

Recall number
Z-1291-2025
Status
Open, Classified
Initiated by the company
Jan 31, 2025
Posted by the FDA
Mar 5, 2025
Recalling firm
DeRoyal Industries Inc
Quantity
714 cases
Product code
GAZ
Distribution
U.S.: IL, MN, NC, PA, and VA O.U.S.: N/A

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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