FDA Medical devices recall ·

DeRoyal AMG Suction Connector Tubing recall

Recall number
Z-1174-2025
Date
(initiated January 15, 2025)
Company / brand
DeRoyal Industries Inc
200 Debusk Ln, Powell, TN, United States
Category
Medical devices › Class II
Classification
Class II
Status
Ongoing
Units affected
224,770 tubes/connectors
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

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

Why was it recalled?

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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

71-2083 Connector Tubing 71-2084 71-C501 Suction Tubing, Connector Item Number: 548501 UDI-DI code: 00749756578981 Lot Numbers: 71-C506 Tubing Suction Connector Item Number: 548527 UDI-DI code: 00749756579032 Lot Numbers: CNWKD04-01 exp 4/4/2029 CWNKD04-02 exp 4/9/2029 CNWKD04-03 exp 4/14/2029 CNWKD04-04 exp 4/19/2029 CNWKD04-05 exp 4/24/2029 CNWKD04-06 exp 4/29/2029 CNWKD04-07 exp 5/4/2029 CNWKD04-08 exp 5/9/2029 CNWKD04-09 exp 5/14/2029 CNWKD04-10 exp 5/19/2029 CNWKD09-02 exp 9/1/2029 CNWKD09-08 exp 9/13/2029 71-C510 Tubing Suction Connector Item Number: 548535 UDI-DI code: '00749756579049 Lot Numbers: CNWKD04-01 exp 4/4/2029 CNWKD04-02 exp 4/9/2029 CNWKD04-03 exp 4/14/2029 CNWKD04-04 exp 4/19/2024 CNWKD04-05 exp 4/24/2029 CNWKD04-06 exp 4/29/2029 CNWKD04-07 exp 5/4/2029 CNWKD04-08 exp 5/9/2029 CNWKD04-09 exp 5/14/2029 CNWKD04-10 exp 5/19/2029 71-C512 Tubing Suction Connector Item Number: 548543 UDI-DI code: 00749756579063 Lot Numbers: CNWKD04-01 exp 4/4/2029 CNWKD04-02 exp 4/9/2029 CNWKD04-03 exp 4/14/2029 CNWKD04-04 exp 4/19/2029 CNWKD04-05 exp 4/24/2029 CNWKD04-06 exp 4/29/2029 CNWKD04-07 exp 5/4/2029 CNWKD04-08 exp 5/9/2029 CNWKD04-09 exp 5/14/2029 CNWKD04-10 exp 5/19/2029 CNWKD09-05 exp 9/7/2029 CNWKD09-07 exp 9/11/2029 CNWKD09-08 exp 9/13/2029 CNWKD10-05 exp 10/9/2029 71-C520 Tubing Suction Connector Item Number: 548551 UDI-DI code: 00749756579070 Lot Numbers: CNWKD04-01 exp 4/4/2029 CNWKD04-04 exp 4/19/2029 CNWKD09-02 exp 9/1/2029 CNWKD10-06 exp 10/12/2029

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

States: Arkansas Arizona Georgia Hawaii Illinois Massachusetts Maryland Minnesota Missouri Mississippi North Dakota New Jersey New York Ohio Oklahoma South Carolina Tennessee Utah Virginia Wisconsin West Virginia

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-1174-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.