—#212943

Product

Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT, REF ACC010381A; 3) NEWBORN RESUSCITATION KIT, REF ACC010381B; 4) NEWBORN RESUSCITATION KIT, REF ACC010381C; 5) PEDS GREY-PINK-RED, REF ACC010395; 6) PEDS PURPLE, REF ACC010397; 7) NEONATAL INTUBATION TRAY, REF ACC010541A; 8) NEONATAL INTUBATION TRAY, REF ACC010541B; 9) NEONATAL INTUBATION TRAY, REF ACC010541C; 10) PEDIATRICS INTUBATION TRAY, REF DYNJAA252.

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K213481
Affected lot / code info: 1) REF ACC010371C: UDI/DI 10193489268188 (ea) 40193489268189 (case), Lot Numbers: 20DDA921, 20EDC042, 20IDC153, 21ADB113, 21CDB435, 21HDB557, 21JDA180, 21LDB244, 22HDB092, 22IDA205, 22JDA908, 22KDA049, 22LDA351, 23EDC611; 2) REF ACC010381A: UDI/DI 10193489800944 (ea) 40193489800945 (case), Lot Numbers: 20BDB854, 20FDA703; 3) REF ACC010381B: UDI/DI 10193489457803 (ea) 401934894578049 (case), Lot Numbers: 20LDA314, 20LDA466, 21ADB162, 21BDB508; 4) REF ACC010381C: UDI/DI 10193489922127 (ea) 40193489922128 (case), Lot Numbers: 21IDA608, 21JDB271, 21KDA979, 21LDA450, 22BDA818, 22FDB822, 22KDB696, 23ADA938, 23CDA005, 23CDB015, 23EDA977, 23FDB762, 23IDB196, 23LDA440, 23LDB579, 24CDA637, 24GDB084, 24IDB423, 24JDB726, 24KDB730; 5) REF ACC010395: UDI/DI 10193489218152 (ea) 40193489218153 (case), Lot Numbers: 20BDC901; 6) REF ACC010397: UDI/DI 10193489218169 (ea) 40193489218160 (case), Lot Numbers: 20CDA453, 20CDA459, 20EDB330; 7) REF ACC010541A: UDI/DI 10195327036980 (ea) 40195327036981 (case), Lot Numbers: 22ADA311; 8) REF ACC010541B: UDI/DI 10195327153649 (ea) 40195327153640 (case), Lot Numbers: 22EDB187; 9) REF ACC010541C: UDI/DI 10198459155765 (ea) 40198459155766 (case), Lot Numbers: 24JDC035; 10) REF DYNJAA252: UDI/DI 10193489297980 (ea) 40193489297981 (case), Lot Numbers: 20EBC867, 20EBD635, 20FBJ920, 22FBF130, 22IBP405

Why it was recalled

Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.

Root cause (FDA determination)

Process change control

Action the firm took

Medline issued a SMITHS MEDICAL URGENT MEDICAL DEVICE CORRECTION notice on 02/24/2025 via email and letter. The notice explained the issue, potential risk, and requested the following: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately.2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form.3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. The login for completing the response form is: Website link: https://recalls.medline.comRecall Reference #: R-25-041-FGX1Recall Code: RECALL CODE4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. On 04/07/2025 Medline issued an updated notice requesting the destruction of all affected units.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: California

Timeline

Recall initiated: 2025-02-24
Posted by FDA: 2025-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212943. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.