DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
- Company
- Deroyal Industries Inc
- Recall Initiated
- January 15, 2025
- Posted
- February 14, 2025
- Recall Number
- Z-1174-2025
- Quantity
- 224,770 tubes/connectors
- Firm Location
- Powell, TN
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
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
Root Cause
Device Design
Action Taken
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