Z-1291-2025Class II

DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal...

Name: Z-1291-2025 DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal...
Creator: DeRoyal Industries Inc
Published: 2025-01-31
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2025-01-31 / Open, Classified

FDA source

DeRoyal Industries Inc began a recall of DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector... on 2025-01-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1291-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-31
Posted: 2025-03-05
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
Product code: GAZ Tubing, Noninvasive
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.
FDA 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 [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].
Quantity in commerce: 714 cases
Distribution: U.S.: IL, MN, NC, PA, and VA O.U.S.: N/A
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1291-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1291-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-05

Product code GAZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)