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DeRoyal AMG Suction Connector Tubing REF recallZ-1174-2025 · DeRoyal Industries Inc · initiated Jan 15, 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

The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in inadequate suction and cause delay in patient care.

FDA root cause category: Device Design

What the company is doing

On 01/15/2025 the firm sent via email an "URGENT! DEROYAL RECALL NOTICE" letter for the Suction Connector Tubing. The letter was informing customers that the suction connector tubing could be defective and that the tubing may not ensure that the yankauer stays intact, and secure to the tubing/yankauer connection for a tight seal. Customers are instructed to: 1.Search their inventory for the affected products and place them in quarantine to prevent further use. 2. Destroy all affected products and complete the NOTICE OF RETURN FORM and indicate all affected products found in their inventory. Return completed form to DeRoyal via fax to 865-362-3716 or [email protected]. 3. If customers have questions regarding credit for the recall, contact Jennifer Marsh at [email protected] or by phone 865-362-4203 or email at [email protected]. If replacement product is preferred, contact DeRoyal Sales Representative or contact Angie Schubert, Assistant Product Director at [email protected]

Recall details

Recall number
Z-1174-2025
Status
Open, Classified
Initiated by the company
Jan 15, 2025
Posted by the FDA
Feb 14, 2025
Recalling firm
DeRoyal Industries Inc
Quantity
224,770 tubes/connectors
Product code
BYY
Distribution
U.S.: ND, NY, VA, WV, NJ, TN, OK, TN, GA, OH, MN, AZ, WI, IL, MA, MD, MO, AR, MS, NY, MS, SC, HI, AR, UT, HI, O.U.S.: Kuwait

Product description

DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

71-2083 Connector Tubing 71-2084 71-C501 Suction Tubing, Connector Item Number: 548501 UDI-DI code: 00749756578981 Lot Numbers: 71-C506 Tubing Suction Connector Item Number: 548527 UDI-DI code: 00749756579032 Lot Numbers: CNWKD04-01 exp 4/4/2029 CWNKD04-02 exp 4/9/2029 CNWKD04-03 exp 4/14/2029 CNWKD04-04 exp 4/19/2029 CNWKD04-05 exp 4/24/2029 CNWKD04-06 exp 4/29/2029 CNWKD04-07 exp 5/4/2029 CNWKD04-08 exp 5/9/2029 CNWKD04-09 exp 5/14/2029 CNWKD04-10 exp 5/19/2029 CNWKD09-02 exp 9/1/2029 CNWKD09-08 exp 9/13/2029 71-C510 Tubing Suction Connector Item Number: 548535 UDI-DI code: '00749756579049 Lot Numbers: CNWKD04-01 exp 4/4/2029 CNWKD04-02 exp 4/9/2029 CNWKD04-03 exp 4/14/2029 CNWKD04-04 exp 4/19/2024 CNWKD04-05 exp 4/24/2029 CNWKD04-06 exp 4/29/2029 CNWKD04-07 exp 5/4/2029 CNWKD04-08 exp 5/9/2029 CNWKD04-09 exp 5/14/2029 CNWKD04-10 exp 5/19/2029 71-C512 Tubing Suction Connector Item Number: 548543 UDI-DI code: 00749756579063 Lot Numbers: CNWKD04-01 exp 4/4/2029 CNWKD04-02 exp 4/9/2029 CNWKD04-03 exp 4/14/2029 CNWKD04-04 exp 4/19/2029 CNWKD04-05 exp 4/24/2029 CNWKD04-06 exp 4/29/2029 CNWKD04-07 exp 5/4/2029 CNWKD04-08 exp 5/9/2029 CNWKD04-09 exp 5/14/2029 CNWKD04-10 exp 5/19/2029 CNWKD09-05 exp 9/7/2029 CNWKD09-07 exp 9/11/2029 CNWKD09-08 exp 9/13/2029 CNWKD10-05 exp 10/9/2029 71-C520 Tubing Suction Connector Item Number: 548551 UDI-DI code: 00749756579070 Lot Numbers: CNWKD04-01 exp 4/4/2029 CNWKD04-04 exp 4/19/2029 CNWKD09-02 exp 9/1/2029 CNWKD10-06 exp 10/12/2029

Devices named in this recall

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

Sources and updates

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