DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
FDA Recall Z-1174-2025 · Posted 2025-02-14
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Recalling FirmDeRoyal Industries Inc
Recall StatusOpen, Classified
Product CodeBYY
Date Initiated2025-01-15
Product Quantity224,770 tubes/connectors
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.
Firm 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]
Root Cause
Device Design
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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