Recall Z-1174-2025 ยท BYY Tube, Aspirating, Flexible, Connecting
DeRoyal Industries Inc
DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
| Date | Feb 14, 2025 (initiated Jan 15, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| 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. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.