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

FDA device recall Z-1174-2025 · posted 2025-02-14 · Open, Classified

Recall details

Recalling firm

DeRoyal Industries Inc

Reason for recall

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 taken

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 recall@deroyal.com. 3. If customers have questions regarding credit for the recall, contact Jennifer Marsh at jmarsh@deroyal.com or by phone 865-362-4203 or email at recalls@deroyal.com. If replacement product is preferred, contact DeRoyal Sales Representative or contact Angie Schubert, Assistant Product Director at aschubert@deroyal.com

Root cause

Device Design

Status

Open, Classified

Product code

BYY

Quantity affected

224,770 tubes/connectors

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

Date initiated

2025-01-15

Date posted

2025-02-14

Location

Powell, TN