DeRoyal Industries Inc recalls DeRoyal AMG Suction Connector Tubing REF: 71-2083
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movementUDI-DI code91 affected lots71-C50654852700749756579032CNWKD04-014/4/2029CWNKD04-024/9/2029CNWKD04-03
+83 more
4/14/2029CNWKD04-044/19/2029CNWKD04-054/24/2029CNWKD04-064/29/2029CNWKD04-075/4/2029CNWKD04-085/9/2029CNWKD04-095/14/2029CNWKD04-105/19/2029CNWKD09-029/1/2029CNWKD09-089/13/202971-C510548535CNWKD04-014/4/2029CNWKD04-024/9/2029CNWKD04-034/14/2029CNWKD04-044/19/2024CNWKD04-054/24/2029CNWKD04-064/29/2029CNWKD04-075/4/2029CNWKD04-085/9/2029CNWKD04-095/14/2029CNWKD04-105/19/202971-C51254854300749756579063CNWKD04-014/4/2029CNWKD04-024/9/2029CNWKD04-034/14/2029CNWKD04-044/19/2029CNWKD04-054/24/2029CNWKD04-064/29/2029CNWKD04-075/4/2029CNWKD04-085/9/2029CNWKD04-095/14/2029CNWKD04-105/19/2029CNWKD09-059/7/2029CNWKD09-079/11/2029CNWKD09-089/13/2029CNWKD10-0510/9/202971-C52054855100749756579070CNWKD04-014/4/2029CNWKD04-044/19/2029CNWKD09-029/1/2029CNWKD10-0610/12/2029
What the firm is doing
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 recall@deroyal.com. 3. If customers have questions regarding credit for the recall, contact Jennifer Marsh at jmarsh@deroyal.com or by phone 865-362-4203 or email at recalls@deroyal.com. If replacement product is preferred, contact DeRoyal Sales Representative or contact Angie Schubert, Assistant Product Director at aschubert@deroyal.com
DistributionShow detailsHide
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
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1174-2025
- FDA device classification · BYYOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.6740The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find DeRoyal Industries IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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