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 Movement

Recall number

Z-1291-2025

Recalling firm

DeRoyal Industries Inc

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

Status

Open, Classified

Initiated

2025-01-31

Posted

2025-03-05

Terminated

not on file

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.

Root cause

Under Investigation by firm

Action

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 recalls@deroyal.com 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 jmarsh@deroyal.com or by phone 865-362-6206 or email us at recalls@deroyal.com. If customers prefer to receive replacement product, contact DeRoyal Sales Representative or contact Angie Schubert, Assistant Product Director, at aschubert@deroyal.com.

Quantity

714 cases

Distribution

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

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

GAZ

Firm FEI

1043214

Firm city

Powell

Firm state

TN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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