FDA Recall Open, Classified

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

Recall: Z-1174-2025 · Initiated January 15, 2025

Recall

Recall Number
Z-1174-2025
Event Number
96130
Firm
DeRoyal Industries Inc
FEI Number
1043214
Product Code
BYY
Status
Open, Classified
Root Cause
Device Design
Initiated
January 15, 2025
Posted
February 14, 2025
Address
200 Debusk Ln, Powell, TN, 37849-4703

Description

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

Reason

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.

Action

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]

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

Quantity

224,770 tubes/connectors