Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT,
FDA device recall Z-1505-2025 · posted 2025-04-10 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.
- Action taken
- 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.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- LRO
- Quantity affected
- 1550 units
- Distribution
- California
- Date initiated
- 2025-02-24
- Date posted
- 2025-04-10
- Location
- Northfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Medline General Surgery Tray (K213481) | Medline Industries, Inc. | 2022-05-24 |