DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fl
Summary
The FDA issued a Class II for DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512 by DeRoyal Industries Inc. 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 inadeq.
Details
Source
Device Recall
External ID
Z-1174-2025
Action Date
2025-02-26
Status
Ongoing
Category
device
Product Description
DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
Lot/Code Info: 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
Quantity Affected: 224,770 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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-15
Company
Powell, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DeRoyal Industries Inc has 183 FDA actions in our database, including 181 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DeRoyal Industries Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DeRoyal Industries Inc have FDA actions?
DeRoyal Industries Inc has 183 FDA actions in our database, including 181 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1174-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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