FDA recall Z-1174-2025

DeRoyal Industries Inc · Class II · device

Product

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

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.

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

Key facts

Status
Ongoing
Initiation date
2025-01-15
Report date
2025-02-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1174-2025